Tag Archive for: Product Development & Management

Convergent Dental

In this blog, we partically recap this customer story, “Convergent Dental Selects Jama Connect,® For Its Live Requirements Traceability” Read the entire story HERE.


In the medical device industry, proving that there are no unvalidated or unverified requirements is critical for compliance. While Convergent prepared to demonstrate compliance with De Novo Classification Request standards, they began to seriously consider the challenges of their documents-based requirements management process.

In this customer story, we examine how Jama Connect helps Convergent Dental increase efficiency and manage complex product development subject to regulatory compliance. Read the full customer story to find out how Convergent Dental has shifted from cumbersome document-based processes to a more modern requirements management solution, resulting in:

  • Audit preparation decreased from three weeks to one day
  • Streamlined review cycles
  • Plans for leveraging Jama Connect for test management

RELATED: Certification and the Role It Plays in the eVTOL Aircraft Market


Convergent Dental chooses Jama Connect to manage compliance through in-depth reviews and to save valuable engineering time.

ABOUT | Convergent Dental

  • Headquartered in Needham, MA
  • Expertise: Creating breakthrough laser technology that completely changes how people think of dentistry.
  • Awards: The Company’s flagship product, Solea®, was voted a Gold Winner for innovation at Edison Awards 2016.

Headquartered in Needham, MA, Convergent Dental, Inc., is the creator of Solea, the world’s first computer-aided hard, soft, and osseous tissue dental laser.

With an isotopic CO2 beam of 9.3 µm, Solea cuts significantly finer and faster than any other dental laser, with virtually no noise or need for anesthesia. Their unique system, with patented technologies and controls, nearly eliminates the need for the drill – the thing that many dread about going to the dentist.

CONVERGENT DENTAL CUSTOMER STORY OVERVIEW

CHALLENGES

  • Manual, cumbersome processes were slowing teams down significantly
  • Difficulty compiling necessary documentation for compliance
  • Proving all requirements are tested

EVALUATION CRITERIA

  • Easy-to-use platform with a low barrier to entry
  • Out-of-the-box configurations
  • Automated traceability

THE OUTCOME AND THE FUTURE

  • Audit preparation decreased from three weeks to one day
  • Streamlined review cycles
  • Plans for leveraging Jama Connect for test management

RELATED: Eight Ways Requirements Management Software Will Save You Significant Money


CHALLENGES

Manual, cumbersome processes were slowing teams down significantly

As a small team, the development team’s motto is that no one has the option to be “dead weight.” So, when their engineers were forced to spend hours manually editing requirements and tracking traceability using Word and Excel documents, it wasn’t great for team morale, or for their pace of development.

While using Word and Excel, they found themselves tracking across multiple documents, all with their own trace matrix tables relating to different requirements. The fallout from this process is that even a single word or letter change in a low-level subsystem requirement led to updating the corresponding requirements documents and their trace matrix tables. So, a single letter turns into not one change but potentially six changes across five different documents.

This manual method of digging through Word documents led to cumbersome requirements management and traceability tracking from engineers whose time should be devoted to systems engineering for product development.

We have a small team with a large amount of features and updates to perform on an ongoing basis. We all work really hard here, and there’s no option to be dead weight. Getting rid of that wasted time in Word and Excel, and getting our test engineers back to work, is the ultimate goal.” – Craig Woodmansee, Electrical Systems Engineer, Convergent

Difficulty compiling necessary documentation for compliance

In the medical device industry, proving that there are no unvalidated or unverified requirements is critical for compliance. While Convergent prepared to demonstrate compliance with De Novo Classification Request standards, they began to seriously consider the challenges of their documents-based requirements management process.

They knew their requirements were tested, but in order to show proof, they had to go through hundreds and hundreds of pages. They tediously combed through all their records, which took weeks, significantly impacted productivity, and slowed time to market.

“So instead of just being able to reference the reports and say, ‘Look, they’re here,’ I had to put together the list and then ask a team member to go dig down those. And that took him a couple of days to dig up all that testing. So that was the loss, time from our test engineers.” – Craig Woodmansee, Electrical Systems Engineer, Convergent

Preparing for the De Novo Submission was a catalyst for this in-depth review of their requirements. If they continued down the path of Word and Excel, an auditor — if they decided to pull on any small little string — would have resulted in more time trying to track down the requirements. This experience was the deciding factor that led them to understand that the Convergent team needed a better tool.


RELATED: A Guide to Good Systems Engineering Best Practices: The Basics and Beyond


EVALUATION

To solve the above challenges, and in order to save valuable time in the development process, the Convergent team knew they needed to move to a modern and proactive requirements management tool.

Many team members had shared their past experience with Perforce Helix, however, when they began evaluating new solutions, they realized they needed more robust configurations and a more intuitive interface than what those could offer.

“When comparing Jama Connect and Helix, ease of use and the interface played a large role in that decision. While Perforce has many strong applications, this specific area is one where Helix fell short.” – Craig Woodmansee, Electrical Systems Engineer, Convergent

The evaluation process for selecting a modern requirements and test management solution ultimately came down to Intland codebeamer and Jama Connect®.

The following capabilities and features were ultimately why Convergent selected Jama Connect:

Easy-to-use platform with a low barrier to entry

Throughout the evaluation process, it was important to the Convergent team that they found a platform that was easy to use, allowing all team members to easily get started without spending significant time learning a complex platform.

As a small team, Convergent needed a platform that would allow them to move quickly and be agile. They didn’t have time to waste when looking for the requirement management tool that would solve their challenges. After completing trials of both Jama Connect and codebeamer, they knew they needed to make a timely decision. They gathered as a team for an internal review where they asked each other questions such as, “How easy was it to learn?”, “How good and intuitive did it feel to use?”, and “How fast can we be onboarded?”

During their evaluation, Jama Connect’s online training videos demonstrated just how easy the platform was to use. After watching tutorials, critical team members felt they already knew how to use the platform and that Jama Connect would provide a good level of support. After their trial, they discovered that the low barrier to entry and quick adoption helped Jama Connect stand out from other platforms and made their team excited when they received approval to start using Jama Connect.

Out-of-the-box configurations

Implementing a new system is a big deal for any company, and while the team knew onboarding a modern requirements management solution would greatly improve the team’s efficiency, they knew that they were facing a relatively significant change. To save time for their quality team, they prioritized finding a solution with out-of-the-box configurations aimed at the design control process.

While evaluating Jama Connect, they found preconfigured design rules that closely matched what they currently used.

“You can’t beat it. It’s too easy. Using the out-of-box configurations, I can just click and view the trace matrix. That was phenomenal.” – Craig Woodmansee, Electrical Systems Engineer, Convergent

Automated traceability

When evaluating solutions, Convergent knew that a key component of their search revolved around a platform’s ability to automatically — and proactively rather than reactively — create traceability from design, all the way through to verification and validation.

What they found was that Jama Connect was the only platform that could create Live Traceability™, the ability to see the most up-to-date and complete upstream and downstream information for any requirement, no matter the stage of systems development or how many siloed tools and teams it spans.

The Convergent team knew that this level of traceability would allow the team to work faster, simplify their process, and improve the quality of their project management.

After importing user needs and requirements, creating relationships, and running tests in Jama Connect, the Convergent team realized that traceability became semiautomatic.

“We don’t have to manually maintain traceability because Jama Connect does it for us. Once requirements are in place, Jama Connect just says ‘if you make a change, then here are all the things it affects.’” – Craig Woodmansee, Electrical Systems Engineer, Convergent

To read the outcome from Convergent Dental’s choice of Jama Connect, read the entire customer story here: Convergent Dental Selects Jama Connect® For Its Live Requirements Traceability


 

Jama Software is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post, we share content sourced from Security – 5 FBI Recommendations for Medical Device Cybersecurity  – which was originally published on September 16, 2022, by Madeline Lauver.


5 FBI Recommendations for Medical Device Cybersecurity

While medical devices are often designed for decades of use in hospitals, the software needed to run them becomes outdated more quickly. This results in devices running vulnerable software on healthcare networks, which can expose patients to physical and cyber threats.

In response to the threats facing medical devices, the Federal Bureau of Investigation (FBI) has released recommendations for the healthcare sector to bolster the cybersecurity of medical devices.

Consequences of medical device cyberattacks

Cybersecurity threats to medical devices can initiate a range of adverse effects. “On the extreme side, you have the scenario where a medical device compromise could directly impact patient safety and potentially be life-threatening,” said Ben Denkers, Chief Innovation Officer at CynergisTek. “What could an attacker do if they took control of an insulin pump or pacemaker?”

While medical device takeovers have the potential to cause life-threatening consequences, many cyberattacks on medical devices lead to system downtime, rather than complete control of devices. “The most common consequence is healthcare organizations must deny service to the individual because the device no longer works or requires supporting infrastructure, which has also been compromised. Where time becomes a critical success factor in many medical emergencies, this can also have severe patient impacts,” said Denkers.


Related: MDIC, HSCC Team Up to Establish Medical Device Security Benchmarks


FBI medical device cybersecurity recommendations

To prevent cyberattacks on medical devices, the FBI released a list of recommended security strategies and technologies for healthcare cybersecurity leaders to adopt, including:

  1. Endpoint protection: Encrypt medical device data, use antivirus protection where able in medical devices, and monitor for cyber threats to the hospital network.
  2. Identity and access management: Use complex passwords and limit the amount of users with accessibility to medical device credentials. If possible, change medical device passwords on a regular basis.
  3. Asset management: Maintain an inventory of all medical devices and track their software lifecycle to replace devices when necessary.
  4. Vulnerability management: Scan devices for vulnerabilities and work with medical device manufacturers to update software.
  5. Employee cybersecurity awareness training: Training should target insider threat prevention and social engineering attack mitigation.

Related: FDA Releases New Guidance on Cybersecurity for Medical Device


This FBI guidance aims to provide the foundation of a robust healthcare security program that reduces medical device cyber risk. “Reducing risk is not a static, one-time process,” said Denkers. “Organizations need to have a program in place to identify ongoing risk and ensure safeguards are performing as designed. Doing so can allow organizations to have an upper hand when dealing with the ever-evolving threat landscape.”

For more medical device security information, read the full FBI recommendations.

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Surgalign

Jama Software is always on the lookout for news on our customers that would benefit and inform our industry partners. As such, we’ve curated a series of customer spotlight articles that we found insightful. In this blog post, we share content, sourced from Mass Device, about one of our customers, Surgalign titled “FDA Clears Surgalign’s Cortera Spinal Fixation System” – which was originally published on August 24, 2022, by Sean Whooley.


FDA Clears Surgalign’s Cortera Spinal Fixation System

Surgalign (Nasdaq:SRGA) has announced that it received FDA 510(k) clearance for its Cortera spinal fixation system.

Deerfield, Illinois-based Surgalign said in a news release that the new flagship Cortera product represents a key product portfolio piece. Surgalign officials see Cotera driving the company’s future growth. It could ensure market gains in the posterior fixation market.

“The Cortera system is a testament to the spine engineering talent and expertise we’ve assembled in very short order, as we moved from zero engineers in the United States following the RTI divestiture two years ago, to approximately 30 today,” said Terry Rich, president and CEO of Surgalign. “Thanks to our team and incredible surgeon partners, we progressed from company inception to FDA 510(k) clearance with a very polished system in approximately 16 months. We are excited with the prospects the Cortera system brings to Surgalign, and those around the world who rely on our technology to drive better patient outcomes.”


RELATED: Convergent Dental Selects Jama Connect® For Its Live Requirements Traceability


More about Cotera

Cortera, a 5.5/6mm rod pedicle screw system, offers both open and minimally invasive surgery (MIS) modules, plus a feature-rich screw design with a comparatively low profile and newly designed locking mechanism.

Surgalign designed Cortera to maximize adoption in the spine market, both today and in the future with evolving techniques and technologies. The company added that Cortera demonstrates the ways in which spinal implants will be deployed with technologies like its own HOLO Portal surgical guidance platform.

The company plans to integrate Cortera with HOLO Portal to create what it labeled “an unrivaled user experience for pedicle screw navigation.” Surgalign also has plans for additional implants and instruments to add to the system over the next few years to expand applications into a majority of posterior fixation spinal procedures.


RELATED: Jama Connect® and FDA 21 CFR Part 11


Surgalign will offer Cortera in a limited market release, which it expects to positively contribute to its 2022 fourth-quarter results and in the coming years.

“The system is hands down the most precise, elegant and comprehensive screw that currently exists in my opinion,” said Dr. Jeremy Smith, chief of spine, Hoag Orthopedic Institute. “I find the system has an evolved sophistication that provides a high-quality user experience and enhanced clinical performance in challenging pathologies.”


Are you a Jama Software customer looking to fill open positions at your organization with prospects who have Jama Connect experience? We’d love to help! Tag us on LinkedIn (@jamasoftware) with your job posting and we’ll share it!


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Risk Traceability

Incorporating Risk Traceability into Manufacturing Production Software and Preparing for the Transition from CSV to CSA

Intro

Over the years, the burden of Computer Systems Validation (CSV) has resulted in medical device manufacturers avoiding implementation of automated manufacturing production systems or upgrading long-outdated versions of software. As part of the FDA’s ‘Case for Quality’ initiative in 2011 to study quality best practice in medical device manufacturing, the FDA found that the burden of compliance, such what is expected for Computer Systems Validation (CSV), deterred technology investments and as a result, inhibited quality best-practice.

As an outcome, the FDA is expected to release a draft guidance in 2022 that outlines their new approach of Computer Software Assurance (CSA) for Production and Quality System Software. The goal is to improve software quality by focusing on the software’s impact to patient safety, impact to product quality, and impact to quality system integrity. Using a risk-based approach, manufacturers can spend more time testing to ensure software meets its intended use, instead of ensuring test protocols and reports are fully scripted are error free.

As the key to right-sizing CSA activities is based on risk, managing risk, and risk traceability and incorporating is a key activity. And there’s no need to wait for the publication of the FDA CSA draft guidance, medical device manufacturers can incorporate these risk management and traceability practices now in their CSV activities.

Keep reading below for best practices on how to extend risk management and risk traceability from the medical device development to your manufacturing production software used to manufacture your devices.

Main Points for How

Consider the product risks and hazards

Even though we are discussing manufacturing production software and the software used on manufacturing equipment, the first step is to consider the product risks and hazards. Start with your master list of hazards, hazardous situations, and associated harms developed during medical device development and determine where and how failures in the manufacturing production software and production equipment can result in those risks and hazards. These are the areas to consider as the highest risks to control, mitigate, and validate.

Next, perform additional risk analysis from the lens of the environment and manufacturing personnel that will operate said equipment and software. It is important to also protect the environment and prevent injury and harm to those interacting with the equipment. You don’t want the unintended release of hazardous chemical reagents or equipment fires that could have been prevented with built-in high temperature shut-down feature.


RELATED: Managing Complexity in Systems Engineering for Product Development with Live Traceability


Create manufacturing production software intended uses and requirements

Just as one determines the intended use and design input requirements of a medical device, the same is to be done for the manufacturing production software and equipment. Incorporate the necessary features as manufacturing requirements (analogous to the design inputs of your medical device) that address the risks identified in the previous step.

One example is based on risk of the product and demonstrates how risk traces from the development of the medical device. Consider the design of a semi-automated assembly machine for a drug-delivery device. The machine aligns and press-fits together two plastic injection-molded halves of the delivery sub-assembly. One of the main product associated risks is ensuring proper flow efficiency to ensure the proper amount of drug is delivered correctly and to the proper anatomical location.

In this case the risk traceability and translation to the assembly machine design inputs is:


RELATED: Application of Risk Analysis Techniques in Jama Connect® to Satisfy ISO 14971


Perform software testing and equipment validation based on risk

Once ready to test the production equipment software and perform equipment validation, incorporate, you guessed it, risk. All manufacturing requirements then need to be verified, however, scale the amount and type of testing for each manufacturing requirement based on the risk. Aspects of the software and equipment that are of high risk, such as preventing severe harm to operators, or the end users and patients of the medical device will have more testing and documentation than those of lower risk.

Document risk traceability of testing and equipment validation

Just as documenting risk traceability for medical device is important, it’s also important for manufacturing production software and equipment. Using a tool like Jama Connect® makes it easy to link your master list of hazards, hazardous situations, and harms to your manufacturing requirements for manufacturing production software and equipment. This increases consistency and efficiency in the risk analysis and prioritizing efforts on where it matters for patient and operator safety. The interface of Jama Connect® also makes the traceability and documentation of the associated testing and validation easy to visualize, alerting teams to gaps and incomplete testing.

Closing

Extending risk traceability from your medical device development to your manufacturing production software and equipment brings focus to what can impact patient safety and scales the testing and validation work appropriately. Incorporate risk and you’ll also be well on your way for the upcoming FDA transition from CSV to CSA.



Systems Development

Jama Software is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post, we share content sourced from Lifecycle Insights – Jama Connect®: Accelerating Systems Development with Requirements Management and Live Traceability™  – which was originally published on August 17, 2022, by John McMillan.


Jama Connect®: Accelerating Systems Development with Requirements Management and Live Traceability™

How does Jama Software®’s approach to managing the vast array of complex engineering requirements provide organizations a competitive advantage? Their approach is a software solution developed specifically to provide unified requirements management and traceability across organization development processes whether that be the traditional V-model, Waterfall, Agile, or otherwise. Jama Connect requirements management software with Live Traceability was designed to help development and engineering organizations improve quality, reduce rework, ensure compliance, and get high-quality complex products, systems, and software to market faster and on budget.

Historically in product development, each engineering discipline utilizes tools that are specifically suited to maximize their ability to be innovative and productive in their own design space. Communication between other disciplines and the broader organization however has historically been siloed or fragmented and often managed through “throw-over-the-wall” manual approaches. Those approaches are error-prone and often result in discovering late-stage issues downstream that result in design rework, delay product delivery, and create cost overruns that impact the organizations’ bottom line.

The Cost of Discovering Late-Stage Issues

When late-stage issues are discovered during integration testing, systems testing, and during final acceptance testing they are expensive to fix. Jama Connect platform was developed to enable organizations to detect and correct requirement and testing issues and solve disjointed discipline problems. This is provided through a requirements management platform designed specifically to help engineering organizations align people, processes, and tools in one concise application early on and throughout product development- when the cost of change is lowest.

Jama Connect was designed to provide unique real-time visibility and actionable insights for the end-to-end product, systems, and software development processes. Within the application, users develop relationship models between each discipline’s tools by way of data elements. These data elements are connected with direct tool integrations with Live Traceability. Once the flow of each element’s connections is defined and reflected throughout the system – should a data element be modified, the connected element stakeholders are alerted, and each discipline can review and address any changes accordingly. The application’s unique open architecture allows integrations with a range of premium solutions across the full ALM-PLM tool ecosystem.


Related: Requirements Traceability Benchmark


What about Integration and Customization?

Jama Connects list of supported tools and plug-in integrations for Live Traceability is already quite extensive and is growing.

  • For Design and Simulation model-based requirements management Connect seamlessly integrates with MBSE and SysML tools including Ansys, MathWorks, Enterprise Architecture, and Catia’s No Magic.
  • For Task Management, Live Traceability is directly supported for Jira, Bugzilla, Azure DevOps, and TFS without any changes required by software developers’ preferred tools, methodology, or field values.
  • For PLM and PLE link requirements to hardware specifications and product line engineering for traceability and impact analysis are seamlessly supported for Teamcenter, Windchill, Aras, Pure-Systems, and BigLever.
  • For Test Automation, live trace requirements and test cases to automated testing results are supported from tools including Tricentis, Ansys, LDRA, TestRail, ZEPHYR, Vector, Jenkins, Bugzilla, and Parasoft.
  • For Risk Management, traceability is supported from Ansys FMEA/DFMEA calculations as well as Microsoft Excel including functions and spreadsheets, is also supported without any changes required to Risk team’s tooling or approaches.
  • For DevOps, Live Traceability is extended down to source code with applications including GitLab, GitHub, and Azure DevOps with no changes required to software developers’ tools or methodologies.

Though Jama Connect provides users with the ability to develop custom model system frameworks, it also includes the frameworks for plans, templates, and checklists that are specifically aligned to industry standards for medical devices, automotive, semiconductor, aerospace, defense/government, software development, and industrial manufacturing. In addition, an extensive list of industry standards and regulations are supported including ISO, IEC, FDA, EU, SEBoK, ARP, DO, and more. These industry-specific standards help organizations ensure end-to-end compliance, mitigate risk, and overall process improvement guidance.

Addressing risk management with system analysis that is tailored to each product’s industry standards and regulations, “left-shifts” risk management throughout the product’s development flow and in turn serves as an integral part of the product lifecycle process. Organizations can standardize and integrate their own risk analysis, evaluation, and risk management processes within Jama Connect’s platform to create a single source of truth for everything risk related.

In addition to risk management, Jama Connect provides critical verification and validation requirements for complex systems via test management. The tool supports customized reporting for proof of regulatory compliance and performs manual user-acceptance testing to ensure products are designed with end-users in mind. The tool generates links to disparate processes, sources, and people that increase visibility and simplifies the user’s path to compliance with traceability of tests back to its requirement. It also traces failed tests to new and existing defects for quick resolution, enabling users to reuse validated requirements saving time when testing consistent features across products.


Related: The Comprehensive Guide to Successfully Adopting Model-Based Systems Engineering (MBSE)


MBSE Platform, Decision Making, and Traceability

MBSE (Model Based System Engineering) is another key area that Jama Connect provides a streamlined and collaborative data-driven approach to in the product development cycle. Jama Connect’s Companion MBSE platform combines requirements, architectures, behaviors, verification, and validation into a single model of the system by applying structure and rules for data and a consistent interface language between the parts of the system. The MBSE platform is designed to help organizations formalize the development, integration, and use of models to inform enterprise and program decision-making. It also allows non-technical stakeholders to visualize a model of the system of interest and interact with its data in familiar views like documents and spreadsheets.

A leading problem that product engineering organizations face is complying with traceability spanning siloed teams and tools (e.g., design, hardware, software, test, risk, quality) creating an increased risk of negative outcomes such as extensive rework, delays, & cost overruns. Requirements traceability across the entire systems development lifecycle is a core tenant of the systems engineering discipline and underpins industry standards to ensure higher quality, faster cycle times, and less costly rework.

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IVDR

This is part 2 of a two-part blog series covering our whitepaper, “The New EU In Vitro Diagnostic Regulation: What’s Changing and What You Need to Know” written by Vincent Balgos, Medial Solution Manager at Jama Software. In this paper, Vincent discusses the In Vitro Diagnostic Regulation (IVDR), developed by the EU Commission (CE), which was created to replace the previous In Vitro Diagnostic Directive (IVDD).

Part 1 of this blog series is available HERE. To read the whitepaper in its entirety, download it HERE.


The New EU In Vitro Diagnostic Regulation (IVDR): What’s Changing and What You Need to Know

The IVDR Overview

With more than 150 pages of regulations, there were many changes to strengthen and grow the path to IVDs marketed and distributed in the EU. The IVDR provides a more comprehensive approach to regulating devices as it encompasses the entire product lifecycle: from initial concept to design and manufacturing, to continual on-market support along maintaining good documentation practices. For the purpose of this paper,
only a few selected topics will be covered in detail with some additional insights from an industry perspective.


Related: Download the Full IVDR Regulation Here


High Level Overview of the IVDR and Key Facts:

Who is impacted?

Medical companies that develop IVD’s marketed to the European Union, and its population. This includes non-EU-based companies that have products in the EU region.

What is impacted?

In-Vitro Diagnostics (IVDs) products and accessories that are used to perform tests on various sample types to help diagnose a condition, detect infections, or monitor drug responses.

When is it happening?

Date of Application: May 26, 2022, where only IVDR applications will be accepted by NB. A two-year window period afterwards to allow companies to transition their IVDD to IVDR certification. By May 2025, all IVDD certificates will be voided, with IVDR covering all placed IVDs in market.

What countries are impacted?

European Union and the United Kingdom specifically, but companies from around the world who have products in the UK or EU are also required to conform.

Why are things changing?

To improve the safety and quality of IVDs in the EU market.

Discuss on Key Topics

Changes to Classifications

A key significant change of the new regulation is how IVD’s are classified. Similar to the previous directive, a risk-based approach (with respects to public and patient) is used to classify IVDs under the new IVDR framework. There are four main classes as listed in the table below, established by seven classifications rules defined in Annex VIII of IVDR.

While there may be nuances to the rules set, these four categories broadly cover the majority of the IVD spectrum. This new classification schema only allows Class A devices to be self-certified by manufacturers, whereas Class B, C, and D require more assessment and certification by notified bodies.

As in similar regulatory pathways, device classification is significant in determining the overall requirements, as the higher the IVD risks, the more onerous the regulatory requirements, and the higher the involvement with an external Notified Body. For example, a new HIV Test would be categorized as Class D, which would require the highest number of internal activities during design, development, on-market support, and associated documentation. This would also require the highest amount of interaction, assessment, and certification from the Notified Body. Furthermore, specific regulations such Post-Market Surveillance, Quality Management System elements, and annual updates to reports are required for higher risk class (C and D) devices.

Based on general research from industry subject matter experts, it was estimated that only 20% required Notified Body certification under the previous IVDD, while 80% did not require certification. With the new classification schema and requirements under IVDR, that ratio has flipped where it is expected that the majority of IVD’s (80%) will now need some Notified Body involvement. This new shift (in engaging Notified Bodies and the new requirement) is significant in many ways as it not only impacts the manufacturers, but also the Notified Bodies as demand for their engagement has risen exponentially. There are some concerns about the current Notified Body capacity, so it is encouraged to start engaging with a Notified Body proactively, as the backlog to engage could be longer than anticipated.

IVDR Chart


Related: The Impact of ISO 26262 on Automotive Development


No Grandfathering Clauses

For certified IVD’s that are currently on-market classified under the IVDD guidance, reclassification to the IVDR categories and recertification to meet the IVDR is required for continual sale and distribution to EU market. Under the IVDR, there are no grandfathering clauses to allow the IVDD devices to remain on market after May 2025. Considering there are many IVD’s in use, the EU established a five-year timeline to allow manufacturers to transition to IVDR. See the timeline below for more details.

IVDR TransitionalSince IVDR’s announcement in 2017, many companies and SME’s (including this author) started to update
their internal procedures, adjust development and documentation activities, and hire additional resources
in response to the impending changes. In addition, remediations to current devices’ Design History Files
(DHFs) to align with regulations were also underway. These include adding additional testing for new
requirements such as performance studies, clinical evaluations, etc. These activities may be significant,
and a major resource pull from other ongoing projects. Therefore, it’s critical to acknowledge that the new
IVDR regulations impact not only future but current IVDs on the market as well.


Related: Medical Device: Reduce Project Risk in the Product Development Process


One Person Responsible for Regulatory Compliance

Under Article 15, a new IVDR requirement is that manufacturers are required to have a regulatory compliance expert in their organization to be responsible for the compliance of the in-vitro diagnostics regulations. This person must be a qualified regulatory expert with previous demonstrated qualification such as 1) formal certification from approved regulatory body and/or 2) minimum of four years of industry experience as a regulatory affairs professional in the IVD field. This role (new for some organizations) provides general regulatory affairs guidance, interpretation of regulations to internal teams, and helps facilitate discussions with Notified Bodies, regulatory agencies, and EU Competent Authorities.

Establishing Risk Management

While not a new requirement to IVD practices, Annex I Chapter I of the IVDR has multiple languages referring to and establishing risk management practices. This further substantiates the EU focus on a riskbased approach when developing devices and encourages many best practices that Jama Software® has seen many of our IVD customers follow.

This new language includes the following requirements:

  • To establish, implement, document, and maintain a risk management system.
  • To enforce continuous and iterative risk management process with regular updates to the risk files throughout the device lifecycle, especially after the product has been launched to market.
  • To reduce risks as far as possible without adversely affecting the benefit-risk ratio and inclusion of this analysis in technical files submission. This includes risks related to use errors of the device.
  • To consider design accommodations to assure that characteristics of safety and performance are maintained during the transport and storage of the product, and for the expected lifetime of the product.
  • To minimize all known and foreseeable risks and be acceptable when weighed against the potential benefits.

This updated language continues the industry practice of risk management that is further established in ISO 14971 “Medical Devices – Application of Risk management to Medical Devices” and TR 24971 “Medical Devices – Guidance on the application of ISO 14971.” Based on the reasons why the IVDR came into fruition (PIP accidents), it can be surmised that an organization’s risk management process will be under significant scrutiny by the Notified Body. Therefore, Risk Management Procedures have been a focal point of update for organizations to strengthen risk practices and ensure compliance. Remediation of risk files may also be warranted for devices currently on the market, or soon to be on the market in the EU.

Based on this author’s experience, this risk activity alone requires significant time and resources to accomplish. Considering some risk files could have significate number of documents (plans, evaluations, reports) with details that require comprehensive review from many stakeholders, this is an effort that needs formal organization support to successfully comply with the IVDR and its compliance timeline. Therefore, it is recommended to prioritize
appropriately and revisit the Risk Management section, and other impacted areas of the IVDR as soon as possible.


Related: Whitepaper: Application of Risk Analysis Techniques in Jama Connect® to Satisfy ISO 14971


General IVDR Guidance for Medical Device Companies

Based on discussions with various IVD customers, general research, and internal experience, we recommend the following guidance:

  • Determine the new IVDR classification for each of your devices on market, or plan to be launched in the EU, and their associated requirements. Consult with Regulatory affairs to proactively affirm
    classification with a notified body.
  • Review and remediate procedures and documents to include new IVDR regulation languages and requirements. Based on your organization’s level of compliance, this could be a significant activity so
    may need management support.
  • Identify the accredited regulatory affairs expert in your organization that will be responsible to drive the activities to comply with the IVDR regulations. This may include updating general regulatory
    procedures, product development processes, and for existing technical documentation.
  • Review and update risk management procedures to include new requirements such as regular updates of the risk files, incorporate use-risk scenarios, and ensuring the benefit-risk comply with
    new language.

As with many types of changes in regulations, these have substantial impact on how organizations and their teams operate in the design, development, and manufacturing documentation of IVDs. It is encouraged to proactively review these new regulations as it may require significant time and resource to adapt to continue developing IVD’s for the European market.


DISCLAIMER
Jama Software is not an accredited regulatory subject matter expert, so these are general guidance and insights from working with many IVD customers, general research, and some internal experience. It is suggested to work with a certified Regulatory Affairs consultant for formal recommendations for your organization.

References:
1. https://www.bsigroup.com/meddev/LocalFiles/en-IN/Technologies/BSI-md-ivd-diagnostic-directive-guide-brochure-UK-EN.pdf
2. https://ec.europa.eu/growth/single-market/ce-marking_en


Accelerate Innovation in Medical Device Development While Adhering to Industry Regulations

With the new IVDR, it is expected that manufacturers will need to shift to a more regimented process of developing, manufacturing, and managing IVD’s. Similar to other regulatory pathways, good requirements management is the best practice in ensuring compliance with regulations, reducing risk, and launching safe and effective products.

Jama Connect® for Medical Device Development helps medical device teams reduce the effort required to achieve regulatory compliance throughout the development process. With this solution, medical device teams can manage design controls for device requirements and related risks, simplifying regulatory submissions and audit preparations while accelerating time to market. Jama Connect creates a digital thread for systems engineering and
ensures Live Traceability™ and alignment across the product development lifecycle to seamlessly connect development solutions and facilitate product success.


Related: Learn What’s Included in Jama Connect’s Medical Device Development Solution


ABOUT THE AUTHOR, VINCENT BALGOS
Vincent Balgos currently leads the Medical Solution at Jama Software. Prior to joining Jama Software, he worked in the medical device / IVD industry for over 17 years with roles in systems engineering, product development and project management. Vincent has successful history in launching new products to the global regulated market, and is experienced in product development, risk management, quality systems, and medical device regulations.

Part 1 of this blog series is available HERE. To read the whitepaper in its entirety, download it HERE.



OSLC

What Is OSLC?

OSLC (Open Services for Lifecycle Collaboration) is an “open” standard designed to facilitate communication between tooling primarily used in engineering disciplines. The initial work was done by IBM in 2009 and in 2013 governance moved to OASIS. The idea behind OSLC is to provide a common layer for tool vendors so that connection between tools can be created without having to write and maintain individual connectors between each set of tools. In theory, this reduces the burden on tool vendors and gives users confidence that tools that support OSLC will interoperate without issue.

What tools support OSLC?

Many tool vendors do not directly support OSLC. Jama Software® integrates with a wide variety of best-of-breed tools and most of them do not come with native OSLC connectors. Of the 25 most prevalent tools that we see in the market, 20% have some OSLC capability, and only 16% have a company- supported connector. Contrast that with the fact that 100% of these tools have a company-supported REST API and you can clearly see the direction of the market.

OSLC services a relatively small niche that often requires consulting and some technical assistance to setup. Given that many of the tools that utilize OSLC are desktop based, the IT environment becomes a challenge for integration. This has led many to rely on third-party vendors to broker the OSLC integration layer and provide the support necessary. At Jama Software we have partnered with MiD and their product Smartfacts to enable this connection. Jama Connect® has a robust REST API and through our partnership with MiD we can support those customers who need an OSLC integration, while extending our integration capabilities to the much wider systems engineering ecosystem.


RELATED: Jama Software® and Sparx Systems Enhance Best-of-breed Tools Integration to Strengthen Live Traceability™ Across Systems Development


Using the integration hierarchy to achieve Live Traceability™

Most companies who are considering an OSLC integration are doing so to improve requirements traceability across their product development process. Requirements traceability approaches range from rudimentary, manual approaches, to automated synchronization across tools. At Jama Software we’re focused on helping our customers achieve Live Traceability™  via automated synchronizations of best-of-breed tools to a common traceability model. For those desktop tools that do not fully support automated synchronization, a lower level of traceability is the best that can be achieved.

Traceability Level

OSLC sits squarely in Level 3.


RELATED: DOORS Next Generation or Jama Connect: A Side-by-Side Look at Requirements Management Platforms


Organizations that are heavily invested in a specific toolchain suite can leverage OSLC to reduce the interop challenge inherent in suites that have been created through acquisition. Embedding user interfaces into other applications and maintaining links allows a user to navigate through the “suite” without having to open each application. When dealing with desktop applications, this can reduce the need to load up each tool individually. It is certainly better than trying to sync information through manual efforts.

In desktop tool scenarios and with tools that do not have a web API, OSLC might be as far as you can go. In which case, Jama Software has you covered. For those who want to move beyond the single user context and achieve Live Traceability, we recommend Level 4 integrations. Utilizing easy-to-implement, universal web standards we’ve helped hundreds of organizations achieve the user-level benefits of contextual data while also elevating the systems engineer’s visibility to the process and organization level.

Contact Jama Software today to find out how we can help you with OSLC and further you on your journey towards Live Traceability.

What is DOORS



EU Regulations

Jama Software is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post, we share content sourced from Medtech Insight – European Regulatory Roundup, July 2022: Threat Of Ongoing Hurdles Masks Progress  – which was originally published on August 1, 2022, by Amanda Maxwell.


European Regulatory Roundup, July 2022: Threat Of Ongoing Hurdles Masks Progress

Executive Summary

The first seven months of 2022 have seen significant progress on documents, tools and new structures needed for the MDR and IVDR implementation. But with major hurdles ahead, in July it was still the problems and not the successes taking center stage.


A significant amount of progress has been made in finalizing documents and processes needed for the implementation of the Medical Device Regulation (MDR) and IVD Regulation (IVDR), as the European Commission’s latest update to its rolling plan, issued in July, showed.

But despite this headway, the outcome of a recent extensive survey by MedTech Europe “clearly indicates an urgent need for immediate action” by decision-makers to help keep needed medical devices available in Europe.

In the analysis of its survey results, MedTech Europe warns that unless swift action is taken, the clinical benefits of new and improved device designs will be more likely to become available to patients in other markets ahead of the EU, requiring patients in Europe to wait until the MDR system is ready.

Indeed, MDR hurdles are deterring some 50% of companies from prioritizing the EU as their launch market, the survey found, and 33% of respondents’ medical devices are currently planned for discontinuation.

The outcomes highlight the lack of responsiveness from notified bodies, unpredictable certification time and non-harmonized interpretations of the same requirements of the MDR, not only among notified bodies as a group but also within them individually.

The urgency of addressing the EU’s regulatory problems was also emphasized by industry association, COCIR, during July. In its paper, the body proposes a series of detailed solutions that it believes would prevent anticipated bottlenecks at notified bodies. Included among its proposals are to: expand the use of remote audits to all products generally, without the need for specific justifications; and allow notified bodies more flexibility in defining the appropriate technical documentation sampling (e.g. lower the number of technical files based on risk class and not groups).

Another July reader favorite on the topic of avoiding a scenario where uncertified devices have to be unnecessarily removed from the market was a Medtech Insight interview with Bassil Akra, CEO of consultancy firm Akra, published at the end of June.

Akra slammed suggestions by the Medical Device Coordination Group that manufacturers were to blame for product certification delays.

He wants regulators to acknowledge that notified bodies are receiving a huge number of applications and have not been able to accept them all because of the magnitude of work involved in dealing with them in the context of new regulations.

Moreover, he said, some manufacturers have not been able to even apply to a notified body yet because their notified body has not been designated and/or others offering services in their area have no capacity.


Related: Notable Changes in the New FDA Draft Guidance – Content of Premarket Submissions for Device Software Functions


Notified Bodies

The Spanish Agency for Medicines and Healthcare Products’ Medical Devices Certification Division was the only new notified body designation in July. This is the first and likely only Spanish notified body under the MDR.

This brings the total number of EU MDR notified bodies to 31, while those designated in the context of the IVDR remain at seven.

Analysis was published during the month highlighting the challenges that manufacturers face in finding a notified body active in their particular product area. It emerged that only two of the 31 notified bodies designated under the MDR are authorized to carry out conformity assessments under all MDR product codes. Four out of the seven designated under the IVDR have full authorization under that regulation.

IVDs

The Implementing Regulation on common specifications for Class D IVDs was finally adopted in July, six weeks after the IVDR took effect.

Class D is the highest risk category under the new IVDR, and legacy IVD Class D must be in full compliance with the new rules by 26 May 2025. Common specifications are like standards but more technically detailed. In this case, they focus particularly on IVD performance characteristics.

New products had to meet the requirements by 26 May this year, and these missing common specifications have been causing challenges and confusion among manufacturers and notified bodies.

Also in the areas of diagnostics, the European Medicines Agency issued in July final guidance outlining the procedure that IVDR-designated notified bodies must follow when seeking a scientific opinion on the suitability of a companion diagnostic (CDx) with the concerned medicinal product.

Eudamed

Delays and uncertainty over the launch of the updated version of the Eudamed medical device database, an MDR and IVDR cornerstone, have caused medtech stakeholders much frustration. In July, however, there was more certainty when the commission published an updated timeline.

The commission expects to declare all six modules of the updated Eudamed medical device database to be sufficiently ready to allow the launch of the full system in the second quarter of 2024.

This will then be followed by two critical deadlines:

  • Six months after the publication of the notice, i.e., Q4 2024, the requirements of Eudamed will become mandatory for the following modules: actor registration; vigilance; clinical investigation and performance studies; and market surveillance.
  • 24 months after the publication of the notice, i.e., Q2 2026, Eudamed will become mandatory for the following modules: UDI/device registration; notified bodies and certificates.

Also in July, new EU guidance was published to help IVD manufacturers understand in detail what they should do pending the full launch of the database.

The 34-page document, MDCG 2022-12 Guidance on harmonized administrative practices and alternative technical solutions until Eudamed is fully functional, features a 30-page table offering alternative solutions to the provisions that were foreseen in the implementation of the IVDR had the database been ready in time for the full application of IVDR on 26 May 2022.

This is not the first text of its kind that has been made available. In May 2021, the month that the MDR fully applied, a similar document was published in the context of the MDR.


Related: The New EU In Vitro Diagnostic Regulation: What’s Changing and What You Need to Know


UK

In the UK, meanwhile, there have been fears that the stormy political waters following Boris Johnson’s resignation as prime minister could impact the timing of the publication of the new, post-Brexit UK medtech regulations. But with new prime minister due to be in place by 5 September, and unlikely to deviate much from the plans of their predecessor, the hiatus is likely to be short.

In the meantime, it has emerged that device manufacturers will have a clearer picture of the post-Brexit system of medtech regulation in the UK once a number of focus groups, to be appointed by the Medicines and Healthcare products regulatory Agency (MHRA), can focus on developing key aspects of guidance that will accompany the new regulations. This step follows publication of the response to the UK consultation on the future shape on the new regulations.

Top Ten List

Below is the list of the top 10 most popular EU and UK regulatory reads in July 2022.
For last month’s round-up see: European Regulatory Roundup, June 2022: Solutions Needed As MDR/IVDR Frustrations Grow

  1. Extensive EU Medtech Regulatory Survey Reveals Scale Of MDR Hurdles And Where Problems Lie 
  2. European Regulatory Roundup, June 2022: Solutions Needed As MDR/IVDR Frustrations Grow
  3. European Commission Expects Eudamed To Be Fully Ready By Q2 2024
  4. MHRA Offers Medtechs Extra Transition Time For UK Regulatory System Compliance
  5. The Good And The Bad News When It Comes To EU Notified Bodies’ Designation Capacity
  6. Akra: Time To Acknowledge EU’s Real Implementation Problems And Stop Scapegoating
  7. Here At Last: EU’s Implementing Regulation On Common Specifications For Class D IVDs
  8. How Stormy UK Politics Could Intrude On Medtech Regulatory Readiness
  9. Spanish AEMPS Latest To Gain Notified Body Designation Under EU Medical Device Regulation
  10. Notified Body Process For Consulting EMA On Companion Diagnostics

RELATED



In Vitro Diagnostic Regulation (IVDR)

This is part 1 of a two-part blog series covering our whitepaper, “The New EU In Vitro Diagnostic Regulation: What’s Changing and What You Need to Know” written by Vincent Balgos, Medial Solution Manager at Jama Software. In this paper, Vincent discusses the In Vitro Diagnostic Regulation (IVDR), developed by the EU Commission (CE), which was created to replace the previous In Vitro Diagnostic Directive (IVDD).

We will share the link to part 2 when it publishes. In the meantime, you can download the eBook HERE.


The New EU In Vitro Diagnostic Regulation (IVDR): What’s Changing and What You Need to Know

Learn more about how IVDR differs from IVDD, key takeaways from the new regulation, and guidance for how to adapt.

Disclaimer: The IVDR regulation is broad and requires focused review and interpretation by each organization — so by no means is this paper intended to be all-exclusive, as it will only discuss select topics.

Jama Software® is not an accredited regulatory body, so these are general discussions and insights from our experience working with many IVD customers, general research, and some internal subject matter expertise. It is suggested to work with a certified Regulatory Affairs consultant (a new IVDR regulation) to obtain formal recommendations for your organization.

If you’re looking for guidance on who to work with when it comes to regulatory compliance, TÜV SÜD has provided certification and testing services for manufacturers and suppliers of medical devices and in vitro diagnostics for over 30 years.

They combine expert medical product testing knowledge with a global network of internationally accredited laboratories and facilities, providing you with a one-stop solution. In fact, Jama Connect® is certified through TÜV SÜD as a software tool for development of medical devices according to IEC 62304. 

Introduction

In May of 2022 a paradigm shift emerged in how In-Vitro Diagnostics (IVD’s) will be developed, managed, and regulated in the European Union (EU). The EU Commission (CE) has developed new regulations named the In Vitro Diagnostic Regulation (IVDR) to replace the previous In Vitro Diagnostic Directive (IVDD). The main goal of the IVDR is to improve upon the quality, safety, and reliability of IVD’s within the European market. This will change the current status quo as IVDR has been predicted to have a significant impact in medical device organizations with IVD sale and business operations.

In this whitepaper, we will provide an overview of the new regulation, discuss some specific topics, and offer considerations for organizations as they adapt to this new paradigm.


Related: The Impact of ISO 26262 on Automotive Development


Overview of the IVDR and The Significant Impact on EU

Figure 1. CE Mark

Prior to the IVDR, the In-Vitro Diagnostics Directive (IVDD) was the governing regulation for devices placed in Europe. Officially adopted in 1997, the IVDD established the regulatory requirements for CE Marking approval for in vitro diagnostics¹. In order to sell and market IVD’s in the European Union, manufacturers need to show compliance with the essential requirements prior to marking the product with the CE label. The CE mark allows for legal distribution
of the IVD within the European Economic Area (EEA)². The CE mark indicates conformity across many different types of products and is based on compliance with specific European regulations based on the product type. See example marking to the left.

For medical devices and IVDs, compliance to the EU Medical Device Directive (MDD) and the EU IVDD was required to obtain CE marking, respectively.


Related: Medical Device: Reduce Project Risk in the Product Development Process


IVDD Overview:

  • IVDD was established in 1997 by the EU for trade within the EEA with 27 EU members plus Iceland, Liechtenstein, and Norway. 
  • IVDD applies to all Reagents, Calibrators, Kit, Instrument, Equipment, Systems used for in vitro diagnostics purposes in the EEA, regardless of origin of design and manufacturing.
  • IVDD is 43 pages providing general requirements. You can read the full document here.
  • Essential Requirements included requirements for design, production, labeling, and the instructions for use (IFU). Some specific requirements included the diagnostic’s analytical sensitivity and specificity, accuracy, repeatability, and reproducibility.
  • There are four general categories that are based on level of risk to public health and/or patient.
    • Annex II List A – Highest risk which require notified body review including HxV’s such as HIV, HBV, HCV
    • Annex II List B – Moderate Risk including IVD’s such as HLA, Glucose monitoring
    • Self-Test – Examples include pregnancy home tests, and cholesterol
    • General – No notified body required as OEM can ‘self-declare’ conformity

Key factors such as the device classification, risk level to patients/public, etc. would determine the manufacturer’s level of approach to developing, manufacturing, and documenting the IVD. A common industry practice for launching an IVD to the global market was that organizations would first launch their products in the EU, and then to broader markets. Due to less rigidity of the IVDD when compared to other countries, it was easier, faster, and more economical for companies to launch there first. The involvement of an external notified body was also less rigid, so many organizations tended to follow the least resistant pathway to market, with many following the ‘self-declaration’/ self-certification pathway. Learnings from the EU launch (e.g., clinical studies) could then be leveraged when then submitting to the more rigid regulatory pathways such as the U.S. Food and Drug Administration (FDA).

This common approach enabled organizations to get new products to the market faster through the regulatory pathway. In the author’s experience, this approach was practiced on many of the IVD’s developed throughout their career in multiple diagnostic applications. The general regulatory roadmap was to have initial launches in EU markets and then proceed with FDA pathway. This provided additional time to work on FDA submission activities since the level of rigidity and documentation was expected to be much higher. However, with the IVDR enforcement now in full effect, it is expected to have a tectonic shift in how manufacturers develop IVDs.


Related: Webinar: Understanding Integrated Risk Management for Medical Device


Compelling Events for Change

As seen with many types of general regulations, changes are commonly in response to mass incidents, generally with negative impact resulting in patient injury and sometimes even death. The US FDA has seen their regulations shift in reaction to mass incidents including the Therac-25 (radiation therapy) and Dalkon Shield (intrauterine device). The accidents led to significant legislative changes to prevent recurrences and improve industry practices to ensure ‘safe and effective’ products.

The emergence of IVDR follows a similar path, where there were European several high-profile events that led to the regulation update. The most notable was the Poly Implant
Prosthesis (PIP) breast implant scandal (based in France) that impacted many patients with high incidents of ruptured implants with unapproved industrial silicone filling. You can read more about the incident here, and the subsequent
clinical recommendations here.

This event led to significant updates to the medical device space with the culmination of the EU Medical Device Regulation published in 2017. Following the MDR initiative, the incumbent IVDD was also overhauled into the new IVDR paradigm which entered into force on May 26, 2017

Stay tuned for Part 2 of this blog series. To read the whitepaper in its entirety, download it HERE.



 

SITA

Jama Software is always on the lookout for news on our customers that would benefit and inform our industry partners. As such, we’ve curated a series of customer spotlight articles that we found insightful. In this blog post, we share content, sourced from Times Aerospace, about one of our customers, SITA titled “SITA unveils eVISA and ETA to transform borders” – which was originally published on July 28, 2022.


SITA unveils eVISA and ETA to transform borders

SITA has launched SITA eVisa and SITA Electronic Travel Authorisation to meet the growing demand from governments for digital visa systems to stimulate national economies after COVID-19.

Image: SITA


RELATED: Customer Story: How SITA Manages Complex Product Development with Globally Distributed Teams


Governments globally are shifting to modern travel authorization solutions, like electronic visas and Electronic Travel Authorisations (ETAs). According to the World Travel & Tourism Council (WTTC), traditional visas – applications made via a consulate or embassy – decreased from 77% in 2008 to 53% in 2018. There is a growing demand for digital travel solutions.

The advantages of digital authorization solutions include improved security, reduced administrative burden, easier travel, and increased visitor flows, promoting spending that benefits local economies and creates employment. For example, one government’s introduction of an eVisa scheme covering 40 plus countries in 2014-2015 led to a 21% increase in international visitor arrivals and the creation of 800,000 jobs accounted for around 20% of the growth seen in the country’s travel and tourism over the period.

The mobile capability of SITA’s new eVisa and ETA capability allows travelers to make applications and provide their biometric information using their personal devices before they travel.

SITA’s eVisa and ETA solutions provide visas containing ICAO’s Visible Digital Seal (VDS), an encrypted bar code that enables visas and ETAs, paper or electronic, to be digitally verified for authenticity, offering enhanced security and fraud prevention.


RELATED: 15 Digital Twin Applications and Use Cases by Industry in 2022


Jeremy Springall, Head of SITA AT BORDERS, said: “Adopting eVisa and ETA supports national prosperity. We’ve productized our proven and robust travel authorization systems to benefit more nations around the world as they shift to digitalize and future-proof their borders. The solutions help countries to cope with growing passenger volumes, improve security and efficiency, and deliver a more seamless travel experience that travelers demand, removing the complexities of applying for traditional visas”.

Springall added: “The adaptability of these two solutions means that they are fully interoperable with existing border control and airline systems. And, they comply with international standards and best practices.”

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