Tag Archive for: Customer Spotlight

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Spyrosoft, titled “CE marking for Medical Device Software: a step-by-step guide” – originally authored by MAŁGORZATA KAWAŁKOWSKA.

CE Marking for Medical Device Software: A Step-By-Step Guide

The recent introduction of EU MDR brought many changes to the CE marking certification process for medical devices. There are more requirements to fulfil, which makes the process more complex and much more time-consuming.

To avoid a scenario where the only thing that stops you from releasing your Medical Device Software to the market is the ongoing CE marking certification, you should know when to take the first steps in this process and how to include it in your overall business strategy.

From this blog post, prepared based on an interview with Krzysztof Minicki, Director of Healthcare and Life Sciences, you’ll get to know the steps of the CE marking process for Medical Device Software. You’ll also learn your responsibilities as a manufacturer, and thus get a better understanding of how to plan and optimise the process to avoid possible bottlenecks.

ToC:

1. Does your software need a CE marking certification?
2. How to get the CE marking certification for Medical Device Software in the EU?
3. How to do CE marking self-certification?
4. How long is the CE marking certification valid?
5. How much does it cost to get CE marking certification?
6. How long does the CE marking certification process take?
7. Need support in the CE marking certification process?

Does your software need a CE marking certification?

Since the introduction of EU MDR in May 2021, the software is now classified as an active medical device. All Medical Device Software that is released to the EU market is required to have the CE marking. Otherwise, it cannot be sold within the EU.

CE MARKING AFTER BREXIT

As of January 1st, 2021, any type of business collaboration between the UK and EU countries got a lot more complicated. So did the CE marking process, which has gone into the transition period ending on January 1st, 2023 – medical companies operating on the British market will be obliged to receive UKCA certification instead of CE marking, with medical products sold in Northern Ireland still requiring the latter. Healthcare products that require to be assessed by a Notified Body will need to be check by an UK Notified Body rather than a EU one.

How to get the CE marking certification for Medical Device Software in the EU?

As a Medical Device Software manufacturer, regardless of whether or not you outsource the manufacturing process, you are responsible for acquiring the CE marking.

In general, the path towards obtaining the CE marking depends on the medical device’s class. Since, in the light of the EU MDR, Medical Device Software is considered as an active medical device, the majority will undergo the upclassification and will belong at least to class IIa.

As per the EU MDR rules, medical devices from classes IIa, IIb and III, have to go through the conformity assessment conducted by a Notified Body. A Notified Body is a third-party organisation, accredited by a European Competent Authority, that checks compliance with the MDR. As a medical device manufacturer, you can select which Notified Body you want to do the assessment for you.

Now, let’s move on now to what the CE marking process for Medical Device Software looks like step by step.

RELATED: 2023 Predictions for Medical Device Product Development

How to do CE marking via self-certification?

1: IMPLEMENT A QUALITY MANAGEMENT SYSTEM

As you determine the classification of your Medical Device Software and appoint a person responsible for regulatory compliance in your organisation, the next step is to create and implement a Quality Management System in accordance with Annex VIII of the MDR and ISO 13485. The compliance must be assessed and certified by a Notified Body. Moreover, the Quality Management System must include Clinical Evaluation, Post Market Surveillance and Post Market Clinical Follow-up plans.

2: PREPARE THE TECHNICAL FILE

In the Technical File you have to include the information about the Intended Use of your Medical Device Software, all the testing reports as well as the Clinical Evaluation Report, your risk management plan and other information specified in Annex II of the MDR.

3: REGISTER IN THE EUDAMED DATABASE

Register your Authorised Representative who will handle the regulatory matters as well as your company as a medical device manufacturer in the EUDAMED database. It’s important to note that the authorised representative is mandatory only for importers outside of the EU.

You don’t necessarily have to do it at this point. It can also be done earlier or later in the process.

4: PREPARE A DECLARATION OF CONFORMITY

The next step for you, the manufacturer, is to prepare a Declaration of Conformity. It’s a legally binding document in which you affirm that your Medical Device Software is compliant with the MDR. At this stage, your product becomes officially CE marked.

5: REGISTER THE MEDICAL DEVICE SOFTWARE IN THE EUDAMED DATABASE

Now it’s time to register your software in the EUDAMED database. Keep in mind, that the UDI number must be placed, for example, in the “footer” or “About” section or other visible and easy-to-access places.

That’s it – your Medical Device Software is ready to be sold on the EU market. Your duty as a manufacturer is now to keep it safe and effective. In this regard, the EU MDR requires that manufacturers conduct Post Market Surveillance Activities. Also, each year you will undergo a Notified Body surveillance audit to ensure continuous compliance with the EU MDR. If you fail to pass it, your CE marking may become invalid.

During the transitional period, the manufacturers are required to perform the Clinical Evaluation and Post Market Surveillance Activities required by MDR, even though their CE marking certification for class I is still valid.

How to CE mark your software if it falls into a higher risk class?

The certification of software that belongs to a higher risk class requires the involvement of a Notified Body. A Notified Body shall audit the quality management system to determine whether it meets all the regulatory and product requirements. If the quality management system conforms to the relevant regulatory provisions, the notified body shall issue an EU quality management system certificate. After that, the declaration of conformity can be signed. Then, the product can be registered in the Eudamed database and finally introduced into the market.

Specific requirements depend on the characteristics and the level of complexity of a product as well as the risk associated with using it, which directly translates into the scope and timeframe of the audit.

How long is the CE marking certification valid?

The CE marking certification for classes IIa, IIb and III is valid for up to five years. After the five-year period, the registration of the certification must be renewed. It’s key to have it on the radar and plan the process in advance. It’s recommended to start the registration renewal at least six months before the certification expires.

How much does it cost to get CE marking certification?

The total cost of the CE marking certification process is proportionate to a device’s class. The higher the class, the bigger the risk and the more complex the process. Hence, the cost is also higher. The CE Marking certification is the most expensive for class III devices and can reach even tens of thousands of dollars.

RELATED: Euro Roundup: MDCG Publishes Guidance on MDR, IVDR Authorized Representative Requirements

How long does the CE marking certification process take?

Since there are still very few Notified Bodies, conducting the conformity assessment may take quite a long time. The time to begin a Notified Body audit varies between half a year and a year. In comparison, under the MDD it was usually a quarter. The time between an audit and approval may take up from two to even seven months.

Why so long? The EU MDR brought in more requirements, especially for the QMS. This makes the whole process more complex and time-consuming.

One of the reasons why it takes so long is also that there are few Notified Bodies that got already accredited in compliance with the new MDR requirements.

Currently, the MDR requires Notified Bodies to make their price list public. However, it’s worth noting that it includes the hourly rates. It’s especially important to keep in mind when introducing a product to the market for the first time (also for the first time since the MDR came into force) as it requires more than one audit to be performed. Firstly, the Notified Body checks the readiness for certification and after a few months it conducts the certification audit. It significantly impacts the cost. The yearly surveillance or recertification audits are performed once per year.

In total, the CE marking certification process may last more than a year. It’s important to take it into consideration when planning your business strategy. For example, you can optimise the process by creating an MVP first and start the CE marking Certification in the meantime, while at the same time developing your product further on.

Need support in the CE marking certification process?

We provide a technical file ready to be assessed for conformity by a Notified Body. Moreover, our specialists can conduct an independent conformity assessment before the official one to check what areas need improvement.

The software we create is compliant with all legal requirements, especially the IEC 62304 and ISO14971. In addition, we provide a Technical File and offer consultation and support with completing the CE marking certification process.

For more information, use the form at the bottom of this blog to contact Krzysztof Minicki, Director of Healthcare and Life Sciences.

Jama Software is always looking 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 a press release, sourced from Cision Distribution by PR Newswire, about one of our customers, magniX titled “magniX Powers First Point-To-Point Flight of an All-Electric Helicopter” – originally published on November 4, 2022.

magniX Powers First Point-To-Point Flight of an All-Electric Helicopter

Flight of Battery-Powered Robinson 44 Helicopter Accelerates Path to Sustainable Delivery of Life-Saving Organs

EVERETT, Wash., Nov. 4, 2022 /PRNewswire/ — magniX, a manufacturer of electric propulsion solutions for aviation, is pleased to have powered the first fully-electric helicopter flight between airfields, in partnership with Tier 1 Engineering. The modified electric Robinson 44 (eR44) helicopter powered with a magniX magni250 electric propulsion unit (EPU) made its historic journey from Jacqueline Cochran Regional Airport to Palm Springs International Airport, arriving on 29 October 2022 at 11:00am PST, in a flight that lasted approximately 20 minutes.

Tier 1 Engineering is developing the magniX-powered eR44 for Lung Biotechnology PBC, a subsidiary of United Therapeutics Corporation, a biotechnology company dedicated to addressing the severe shortage of transplantable organs in the U.S. The magniX EPU was retrofitted into the helicopter together with a battery system developed by Tier 1 Engineering, specialists in the design and development of electric aircraft. The eR44 is designed to deliver human and manufactured organs for transplant with zero carbon emissions at the point of use.

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“Building from our first flight of the eR44 helicopter last June, the successfully completed point-to-point flight takes us a step closer to the sustainable transport of life-saving organs,” said Nuno Taborda, CEO of magniX. “magniX is excited to be part of an initiative that will positively affect those in need of urgent medical care. This is only the start of the applications for electric helicopters, which have a bright future as low-cost, carbon-free, reliable alternatives to combustion engine models.”

magniX Celebrates Another Industry First

Since December 2019, magniX has also provided the technology to power a number of first flights, including that of Harbour Air’s “eBeaver”, a Cessna “eCaravan” and, most recently in September 2022, Eviation’s all-electric commuter aircraft, Alice. This point-to-point flight of an electric rotary aircraft represents the latest first for the industry-leading electric solutions company. Tier 1 Engineering is currently working with the FAA on the eR44 project to obtain a Supplemental Type Certificate (STC). Lung Biotechnology PBC plans to acquire a fleet of sustainable aircraft to transport transplant organs.

“We are committed to charting a new path forward for the zero-carbon delivery of life-saving organs,” said Dr. Martine Rothblatt, one of the helicopter’s pilots and CEO of United Therapeutics Corporation. “Saturday’s point-to-point flight proves that the technology necessary for our mission is already here, as we actively work with the FAA to certify the eR44 helicopter.”

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“Together we achieved an incredible outcome for the world’s first airport-to-airport cross-country all-electric helicopter flight,” said Glen Dromgoole, President of Tier 1 Engineering. “magniX has again demonstrated the reliability and power of its electric propulsion units, and we’re proud to continue this journey to create sustainable options for organ donation and, ultimately, help save lives.”

About magniX

Headquartered in Everett, Washington State, U.S., magniX is dedicated to leading an era of environmentally-friendly and sustainable aviation. magniX has developed a family of flight-proven electric propulsion units (EPUs) and is fast maturing its energy storage systems (ESS) for commercial aviation. With high levels of reliability, unparalleled performance and operational practicality, magniX is leading the aviation industry into a sustainable future. magniX is a subsidiary of the Clermont Group, an international business group headquartered in Singapore. For further information, please visit www.magnix.aero.

Contact
FINN Partners for magniX
magniX@finnpartners.com

SOURCE magniX

Jama Software is always looking 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 WIRED, about one of our customers, Illumina titled “The Era of Fast, Cheap Genome Sequencing Is Here” – originally published on September 29, 2022, by Emily Mullin.

The Era of Fast, Cheap Genome Sequencing Is Here

Illumina just announced a machine that can crack genomes twice as fast as its current version—and drive the cost down to $200 a pop.

THE HUMAN GENOME is made of more than 6 billion letters, and each person has a unique configuration of As, Cs, Gs, and Ts—the molecular building blocks that make up DNA. Determining the sequence of all those letters used to take vast amounts of money, time, and effort. The Human Genome Project took 13 years and thousands of researchers. The final cost: $2.7 billion.

That 1990 project kicked off the age of genomics, helping scientists unravel genetic drivers of cancer and many inherited diseases while spurring the development of at-home DNA tests, among other advances. Next, researchers started sequencing more genomes: from animals, plants, bacteria, and viruses. Ten years ago, it cost about $10,000 for researchers to sequence a human genome. A few years ago, that fell to $1,000. Today, it’s about $600.

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Now, sequencing is about to get even cheaper. At an industry event in San Diego today, genomics behemoth Illumina unveiled what it calls its fastest, most cost-efficient sequencing machines yet, the NovaSeq X series. The company, which controls around 80 percent of the DNA sequencing market globally, believes its new technology will slash the cost to just $200 per human genome while providing a readout at twice the speed. Francis deSouza, Illumina’s CEO, says the more powerful model will be able to sequence 20,000 genomes per year; its current machines can do about 7,500. Illumina will start selling the new machines today and ship them next year.

“As we look to the next decade, we believe we’re entering the era of genomic medicine going mainstream. To do that requires the next generation of sequencers,” deSouza says. “We need price points to keep coming down to make genomic medicine and genomic tests available much more broadly.”

Sequencing has led to genetically targeted drugs, blood tests that can detect cancer early, and diagnoses for people with rare diseases who have long sought answers. We can also thank sequencing for the Covid-19 vaccines, which scientists started developing in January 2020 as soon as the first blueprint of the virus’s genome was produced. In research labs, the technology has become essential for better understanding pathogens and human evolution. But it still isn’t ubiquitous in medicine. That’s in part because of the price tag. While it costs around $600 for scientists to perform sequencing, clinical interpretation and genetic counseling can drive the price to a few thousand dollars for patients—and insurance doesn’t always cover it.

Another reason is that for healthy people, there’s not yet enough evidence of benefits to prove that genome sequencing will be worth the cost. Currently, the test is mostly limited to people with certain cancers or undiagnosed illnesses—although in two recent studies, around 12 to 15 percent of healthy people whose genomes were sequenced ended up having a genetic variation that showed they had an elevated risk of a treatable or preventable disease, indicating that sequencing may provide an early warning.

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For now, researchers—not patients—will likely benefit most from cheap sequencing. “We’ve been waiting for this for a long time,” says Stacey Gabriel, chief genomics officer at the Broad Institute of MIT and Harvard, of the new improvements. “With greatly reduced costs and greatly increased speed of sequencing, we can sequence way more samples.” Gabriel is not affiliated with Illumina, but the Broad Institute is something of an Illumina power user. The institute has 32 of the company’s existing machines and has sequenced more than 486,000 genomes since it was established in 2004.

Gabriel says there are a number of ways that researchers will be able to apply added sequencing power. One is to increase the diversity of genomic datasets, given that the vast majority of DNA data has come from people of European descent. That’s a problem for medicine, because different populations might have different disease-causing genetic variations that are more or less prevalent. “There’s really an incomplete picture and a hampered ability to translate and apply those learnings to the full population diversity in the world,” Gabriel says.

Another is to boost the size of genetic datasets. In the early 2000s, when the Broad Institute started a project to search for genes related to schizophrenia, researchers had 10,000 genomes from people with the condition, which didn’t yield many insights, Gabriel says. Now, they have amassed more than 150,000.

Comparing those genomes to those of people without schizophrenia has allowed investigators to uncover multiple genes that have a profound impact on a person’s risk of developing it. By being able to sequence more genomes faster and more cheaply, Gabriel says they’ll be able to find additional genes that have a more subtle effect on the condition. “Once you have bigger data, the signal becomes clearer,” she says.

“This is the kind of thing that shakes up everything you’re working on,” agrees Jeremy Schmutz, a faculty investigator at HudsonAlpha Institute for Biotechnology, of new sequencing technology. “This reduction in sequencing cost allows you to scale up and do more of those large research studies.” For Schmutz, who studies plants, cheaper sequencing will allow him to generate more reference genomes to better study how genetics influence a plant’s physical characteristics, or phenotype. Large genomic studies can help improve agriculture by accelerating the breeding of certain desirable crops, he says.

Illumina’s sequencers use a method called “sequencing by synthesis” to decipher DNA. This process first requires that DNA strands, which are usually in double-helix form, be split into single strands. The DNA is then broken into short fragments that are spread onto a flow cell—a glass surface about the size of a smartphone. When a flow cell is loaded into the sequencer, the machine attaches color-coded fluorescent tags to each base: A, C, G, and T. For instance, blue might correspond to the letter A. Each of the DNA fragments gets copied one base at a time, and a matching strand of DNA is gradually made, or synthesized. A laser scans the bases one by one while a camera records the color coding for each letter. The process is repeated until every fragment is sequenced.

For its latest machines, Illumina invented denser flow cells to increase data yield and new chemical reagents, which enable faster reads of bases. “The molecules in that sequencing chemistry are much stronger. They can resist heat, they can resist water, and because they’re so much tougher, we can subject them to more laser power and can scan them faster. That’s the heart of the engine that allows us to get so much more data faster and at lower costs,” says Alex Aravanis, Illumina’s chief technology officer.

That said, while the cost per genome is dropping, for now, the startup cost for a machine itself is steep. Illumina’s new system will cost around $1 million, about the same as its existing machines. The high price tag is a key reason they’re not yet common in smaller labs and hospitals, or in rural regions.

Another is that they also require experts to run the machines and process the data. But Illumina’s sequencers are completely automated and produce a report comparing each sample against a reference genome. Aravanis says this automation could democratize sequencing, so that facilities without large teams of scientists and engineers can run the machines with few resources.

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Illumina isn’t the only company promising cheaper, faster sequencing. While the San Diego-based company currently dominates the marketplace, some of the patents protecting its technology expire this year, opening the door for more competition. Ultima Genomics of Newark, California, emerged from stealth mode earlier this year promising a $100 genome with its new sequencing machine, which it will begin selling in 2023. Meanwhile, a Chinese company, MGI, began selling its sequencers in the United States this summer. Element Biosciences and Singular Genomics, both based in San Diego, have also developed smaller, benchtop sequencing machines that could shake up the marketplace.

Ultima’s machine design has replaced the traditional flow cell with a round silicon wafer just under seven inches in diameter. Josh Lauer, the company’s chief commercial officer, says the disc is cheaper to manufacture and has a bigger surface area than a flow cell, allowing more DNA to be read at once. Because the disc rotates like a record under a camera instead of moving back and forth like flow cells do, Lauer says it requires smaller volumes of reagents and speeds up imaging. “We think this will enable scientists and clinicians to do more breadth, depth and frequency of genome sequencing,” he says. “Instead of just looking at tiny parts of the genome, we want to look at the whole genome.”

Ultima’s machine isn’t widely available yet, and the company hasn’t released the price, though Lauer says it will be comparable to other sequencers on the market.

The increased competition could be a boon to the genomics field, but research is often slow to translate to health improvements in real people. It will likely take time before patients see a direct benefit from cheaper sequencing. “We’re at the very, very beginning,” deSouza says.