Tag Archive for: Compliance & Regulation

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.


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.


Rimac

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 InsideEVs, about one of our customers, Rimac Nevera titled “Rimac Nevera Receives US Homologation And Green Light For Deliveries” – which was originally published on July 12, 2022, by Mark Kane.

Rimac Nevera Receives US Homologation and Green Light For Deliveries

According to CARB, it has 287.28 miles (462 km) of UDDS range.

Rimac Nevera is one step closer to the US market launch, as the all-electric supercar received US homologation (on top of EU, secured earlier).

The company’s founder Mate Rimac shared info via Facebook, with screenshots of EPA and California Air Resources Board (CARB) documents, confirming certification of the Rimac Nevera.

“Last documents for US homologation arrived as well (EPA & CARB). Nevera is now EU and US homologated and ready for delivery.”

The CARB document includes the range value of the Rimac Nevera under Urban Dynamometer Driving Schedule (UDDS) test cycle, which at 287.28 miles (462 km) is interestingly lower than anticipated for a car with a 120 kWh battery.

RELATED: Accelerating the Future of Automotive with Rimac Automobili and Jama Connect

For reference, the WLTP range in Europe was targeted at up to 550 km (342 miles). We are curious what the EPA range will be, especially since it’s often below UDDS.

Anyway, the Croatian manufacturer is already completing the first cars for customers. According to Mate Rimac, the Nevara #002 (out of 150 planned) is on pre-delivery testing on roads around Zagreb, Croatia.

“Also, Production Car #002 is on pre-delivery testing on roads around Zagreb today. But not up to us to show pictures – that will be done by the customers when they want to. Probably coming in a couple of weeks…”

The Rimac Nevara is the quickest production electric car so far, but the spectacular performance (including “destruction” of the Tesla Model S Plaid at a drag strip) comes at a cost of around €2 million ($2 million).

RELATED: Ensuring Safety and Security for Automotive Development

Rimac Nevera specs:

  • 287.28 miles (462 km) of UDDS range
    up to 550 km (342 miles) of WLTP range (preliminary)
  • 120 kWh battery; liquid cooled
    800V system voltage (maximum 730 V)
    Lithium Manganese Nickel chemistry
    Cell format: cylindrical 2170
    number of cells: 6,960
  • Acceleration
    0-60 mph (96.5 km/h) in 1.85 seconds (*high-friction surface, one foot roll-out)
    0-100 km/h (62 mph) in 1.97 seconds (*high-friction surface, one foot roll-out)
    0-300 km/h (186 mph) in 9.3 seconds (high-friction surface, one foot roll-out)
    1/4 mile (402 m) time in 8.6 seconds
  • DragTimes’ run: 8.582 seconds at 167.51 mph (269.5 km/h)
  • Top Speed of 412 km/h (258 mph)
  • All-Wheel Drive
  • System output of 1,408 kW (or 1.4 MW; 1,914 hp) and 2,360 Nm
    four independent surface-mounted, carbon-sleeve, permanent-magnet electric motors
    four independent inverters and gearboxes
  • Rimac’s intelligent All Wheel Torque Vectoring system (R-AWTV)
    front motors: 250 kW (340 hp) and 280 Nm each, combined with two single speed gearboxes (two independent gearboxes – one at each outer end of the axle)
    rear motors: 450 kW (612 hp) and 900 Nm each, combined with double single speed gearbox (two gearboxes in one housing between the motors)
  • AC charging (on-board): 22 kW three-phase
  • DC fast charging: up to 500 kW (0-80% SOC in 22 minutes, using ultra-fast charger)
  • Length 4750 mm; Width 1986 mm; Height 1208 mm; Wheelbase 2745 mm
  • Weight of 2,150 kg
  • Tires: Michelin Pilot Sport 4S (Front 275/35 R20; Rear 315/35 R20)
RELATED


Product Team

A product team and an engineering team could be viewed as two sides of the same product development coin. So, ask yourself, “Who only uses half a coin?” It’d be like using just one side of your brain.

In a perfect product development world, communications are seamless, specifications are clear, and product and engineering teams work without friction. Except, we live in the real world where life is messy, responsibilities overlap, specifications change, and the way teams interact can introduce friction.

In the rush of product development, it’s important to establish boundaries for each team while also working as a unit and develop processes to head off trouble before it begins. This only gets more complicated with bigger and more technical projects.

The Product Team

Before the first line of code is written, someone needs to own the product and fully understand what’s being built and why.

It’s the product team that should understand the why, inside and out. From ideas that turn into research that guides specifications to conversations with customers, the product team is lining up the rubber ducks in neat little rows so engineers can focus on the technical problems. What do the ducks look like? How do they sound when squeezed? And what do users want?

Product teams tend to dream big, but they must also manage expectations and align goals with those of the overall business. That’s why it’s a good idea to get an engineering lead involved early in the planning process to build cross-team cohesion.

For example, if you’re building the next great blogging platform, maybe your commenting mechanism is the “killer feature” and the engineering team needs to focus on issues like authentication and moderation tools. How much of the apple can we bite off at a time? Such questions circle back to product team responsibilities like the business goals and strategy. Prioritization is the byproduct of open talks between teams to determine what is needed and what can be delivered on time.

It’s also worth noting that tension between teams is a natural and healthy aspect of working cross-functionally. Each team has its own set of internal goals, but those must align with overall strategic goals for the company (or product).

The product manager serves as the CEO for whatever is being built. If he or she asks for the moon, there must also be the understanding of the challenges that await.

We’ve probably all been in a meeting where something ambitious is proposed and the engineering team rolls their eyes, thinking, “If we could build that we’d all be zillionaires.” The balance here is one of awareness.

Technical teams need to be just as ambitious as their product counterparts, and that means understanding a little bit of each other’s worlds to know what’s feasible and what will cause deadlines to crash.

https://resources.jamasoftware.com/blog/a-guide-to-good-systems-engineering-practices-the-basics-and-beyond

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

The Engineering Team

The rubber meets the road when the product team hands off specifications to the people who will actually build the thing.

Engineering is the technical team of developers and managers who write the code and create the front end, so the clearer the guidance they get upfront, the better. That doesn’t mean micromanaging from the product team, but it does mean regular check-ins to increase buy-in, build cohesion, and avoid surprises.

Going back to our blogging platform example, let’s say there are some whiz-bang features on the front end that will dazzle users. A product manager might tell engineering to focus on those features. If the product team has done its job, the tech leads can accurately inform them how long it will take to implement the features.

However, they could just as easily warn the product team that there are backend issues to tackle to enable those frontend goodies. There’s no way to have one without the other, and this is another area where the tension comes in, as timelines might have to be readjusted.

When teams understand that they’re on the same side, everyone can take a step back to see the full map and make sure they’re headed to the same destination. It’s also where teams who understand each other excel.

Product must comprehend the engineering team’s needs, and engineering must grasp the importance of the product planning that came before. Maybe it’s a matter of a few sprints to see where the marquee feature is in a week. Or perhaps a lower-priority feature that really puts a kink in the line just needs to be delayed.

Either way, the only solution is to drop the egos and hash things out in realistic terms. Again, if product has done the job, both teams should be like looking at the release like a big X on a treasure map and walking there together.

RELATED: The Complete Guide to the Systems Engineering Body of Knowledge (SEBoK)

One Team

If all of this sounds familiar, you’re not alone. Everyone in these teams is working under a number of different dynamics.

It could be that product feels it has defined everything so thoroughly that the engineering team can take the ball to the goal after a simple handoff. Of course, that is rarely the case.

More likely, there’s a stream of reviews to comb through and see how things are advancing (which, if you’re using the right solutions, can be handled faster and with less meetings) while moving the goalposts when one side reports a change in the variables.

So, what do you do? Learn to function as one team while respecting each other’s territory. After all, you’re all headed to the same goal. Even if your organization compartmentalizes each side, find a way to cross the streams. For many, the move from Waterfall development to Agile created a more efficient, functional model for developers, and a variation on that theme can serve you here as well.

First, create a great set of fundamentals with your product team by bringing in engineers as early in the planning stages as possible. Ask what’s feasible and go to lunch and dream about unlimited budgets. Integrate the engineering team as best you can, because their insight will save squabbling down the road. Then create specifications that are realistic.

Next, empower each side of the table with respect. Product may want the moon tomorrow and engineering will explain how much lift is needed to get there, so friction is inevitable. In the big picture though, both sides are arguing for the same goal, so keep that front-of-mind and allow room for either side to concede territory as needed. Conflict is normal and necessary, but if one side is utterly powerless and is continuously overrun, the “team” notion falls apart and the idea of collaboration breaks down.

If both teams are aligned, truly listening and making necessary adjustments, there’s no reason even large, complex projects can’t be finished on time and on budget. It takes work, especially if an organization is averse to cross-functional teamwork.

The payoff, though, is happier, more productive teams who share in the product’s success. It’s up to both sides to come to the table ready to cooperate.

Does that mean having certain boundaries? Yes! It’s unlikely the engineering team has done the market research to say whether a feature is desired by users. And it’s equally unlikely that the product team will accept a major delay for technical implementation if it was in the original specification.

Each side has a job to do, but the key is understanding that everyone is marching under the same umbrella in the end. That’s why it’s important to play the role you’re in while listening and accepting the experience and knowledge of the entire team.


This is part one of a two-part series. Part two is available here.

FDA Inspection

FDA inspections can be daunting, especially for an organization that is expecting its first one. In part one of a two-blog series, here are five best practices to prepare your organization for success:

1: Understand why the FDA will perform an inspection

The first step in preparing for a successful FDA inspection is understanding why your facility and Quality System (QS) are being inspected. Whether it’s a pre-approval inspection, a biennial audit, or for‑cause, knowing where the FDA will be focusing will help you focus on how to prepare.

2: Learn what an FDA Investigation is like

Another key understanding is that an FDA inspection is not just another audit. The inspection is not the same as an ISO 13485 certification audit, internal audit, or supplier audit. While not all FDA investigators are identical, in general, FDA inspections are much more rigorous and intense in nature.

Thus, educating yourself and your organization on what to expect during an FDA inspection is important. Many resources are available at the FDA’s website, including guides for medical device manufacturers and their Quality System Inspection Technique (QSIT). Another aspect to know is an inspection will assess compliance to 21 CFR 820 (the Quality System), as well as other parts, including 803 (MDR), 821 (Tracking), 806 (Corrections and Removals), and 807 (Registration and Listing).

RELATED POST: The Rapid Rise of Digital Health Technology: Challenges and Keys to Success

3: Identify Subject Matter Experts (SMEs) for processes and devices

Identify subject matter experts (SMEs) for QS processes and devices. These individuals should be knowledgeable with the subject matter, as well as able to communicate well with the investigator. While your organization’s records should speak for themselves, having an individual who can guide an investigator as necessary makes the inspection run more smoothly and efficiently.

4: Perform an assessment and address gaps

For an organization preparing for its first FDA inspection, review your Quality System procedures and records, with increased attention to the areas relevant to the anticipated focus of the inspection.

Many organizations also design their Quality Systems for ISO 13485 compliance, and while ISO 13485 and the FDA Quality Systems Regulations (QSR) are similar, there are some differences. Note, the FDA has indicated that harmonizing and modernizing the Quality System Regulation (QSR) with ISO 13485 is an active initiative. Until then, ensure your Quality System covers all aspects required by the FDA. One available tool that maps the FDA 21 CFR to ISO 13485:2016 is AAMI TIR102:2019.

Also audit your recent Quality Systems records for 2 reasons, 1) identify any issues for compliance to your organization’s procedures, and 2) familiarize yourself with any issues so they can be reviewed clearly by the SME if those topics come up in the investigation.  Use a reputable auditor that is familiar with FDA inspections and how investigators are trained. Involve your SMEs so they are prepared as well.

Records to review include those associated with the particular device of focus. For example, in a Pre-Market Approval (PMA) inspection, ensure an SME can walk an investigator through the Design History File of the device to demonstrate the design controls were adequately met. Before the FDA arrives is a good time to ensure that there is evidence that all design inputs are verified and all user needs and all intended uses have been validated.

Ensure that your firm is registered and that your device listings are up to date.

RELATED POST: Complying with FDA Design Control Requirements Using Requirements Management Principles

5: Perform mock inspection(s)

Mock inspections serve a number of purposes when preparing for an FDA inspection. They allow individuals that may be involved, including SMEs, an opportunity to practice, can identify areas of concern that can be addressed before the FDA arrives, and give your organization an opportunity to practice the logistics of hosting an FDA inspection.

Again, use an experienced auditor familiar with FDA inspections and the mindset of FDA investigators. 

As with any large endeavor, preparation is key. These best practices provide you with the path and resources to educate and prepare your organization for an FDA inspection.

Visit part two of this blog series for best practices and tips regarding the logistics of running a smooth and efficient inspection.

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