Easy Medical Device Podcast

https://www.youtube.com/embed/anQRz2weaqo?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

As you may know, the new Medical Device Regulation is asking for more Clinical Data to be able to prove that your product is safe. I am sure that you are wondering about the possibilities for you to collect clinical data for your product.

In this episode, David Rutledge from Global Strategic Solution will share with us 6 ways to collect clinical data for your Medical Devices. He will also help you understand which one is more suitable for your situation.

David also shared with us a presentation that you can download from the links listed below. Don’t hesitate to reach our to him if you have more questions.

Who is David Rutledge

David R Rutledge, Pharm.D., FCCP, FAHA is a results-oriented consultant for clinical evaluation and investigation, clinical risk management, regulatory, and quality. He brings 25 years’ global experience with agencies such as US FDA, Brazil ANVISA, Mexico COFEPRIS, NMPA (China FDA), S Korea Ministry of Food and Drug Safety, Hong Kong, Malaysia, Health Canada, Australia TGA, Thailand FDA, Japan PMDA, EMA, Saudi FDA, CDSCO of India and several Notified Bodies, e.g., BSI, DEKRA, Medcert, and TÜV SÜD.

He previously accepted a 4-year appointment from the United States Department of Health & Human Services to serve as the Industry Representative on the FDA’s General Hospital and Personal Use Devices Advisory Committee in FDA’s Center for Devices and Radiological Health (CDRH).

He is certified as a Lead Auditor for Quality Management Systems ISO13485 and holds certificates for Design Control, Risk Management, Six Sigma, and CAPA. Dr. David R Rutledge was formerly a Director with Abbott Medical Devices in Global Clinical Research and then Global Regulatory Operations. He has managed budgets up to $23.3 million. 

Links

• David Rutledge Linkedin: https://www.linkedin.com/in/david-rutledge-9291609/
• Download Presentation: https://mailchi.mp/easymedicaldevice/clinical_data_source

The post 6 ways to collect Clinical Data with David Rutledge appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

With the MDR, more and more clinical data are needed. But how will you collect them. David Rutledge will show you 6 ways to collect those data and the pros and cons for each of them. The post 6 ways to collect Clinical Data with David Rutledge appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/BbNUE01TnYc?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

In this second part of the discussion with Erik Vollebregt, we will continue to help Medical Device manufacturers regarding the MDR Corrigendum 2. But we will also include more information about pure Class I devices.

The manufacturers with only class I devices will be surprised as there are also more requirements they have to follow per MDR. For example the creation of a QMS, the registration of economic operators, UDI…

So you should really understand those requirements as this can also increase the cost. I used the example of someone contacting me from the US to register an FDA class 1 product in EUROPE. And when I listen to him all the requirements and the cost of it, he was really surprised.

Learn to remain compliant just by listening to this episode.

Who is Erik Vollebregt

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A.

Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms.

He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.

Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Link to the episode

• Episode 53: https://podcast.easymedicaldevice.com/53
• Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt/
• Axon Lawyer Website: https://www.axonlawyers.com/
• Slide Presentation: https://www.slideshare.net/ErikVollebregt/mdr-and-class-i-medical-devices-presentation-203092176
• CEN/TR 17223:2018 MDR vs ISO 13485: http://tidd.ly/830baa
• Blog post on Corrigendum 2 (Erik Vollebregt): https://medicaldeviceslegal.com/2019/12/09/corrigendum-2-and-the-potential-consequences-for-class-i-devices/
• Corrigendum 2 link: https://data.consilium.europa.eu/doc/document/ST-13081-2019-INIT/en/pdf
• Class I technical file template: https://school.easymedicaldevice.com/shop

The post Class I Medical Devices under MDR with Erik Vollebregt (PART 2) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Before to look at this episode, you should go to Part 1. On this second part we'll continue to discuss Class I up-classified situation and then pure Class I devices under MDR. The post Class I Medical Devices under MDR with Erik Vollebregt (PART 2) appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/JCO6mZBRYWk?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

There are some changes to some Class I devices. But at the time of this episode, there is still 1 vote remaining before acceptance of the Corrigendum.

Following the release of Corrigendum 2 of the Medical Device Regulation MDR 2017/745 and IVDR 2017/746, there is a significative change related to Medical Device class I that is up classified.

In this first part of this podcast episode, I have invited Erik Vollebregt to clarify the situation and help us understand the consequences of this corrigendum.

If you are a class I manufacturer, you need to look at that as there will be a lot of information that can help you. There are also a lot of consequences if you are not compliant, even RETROSPECTIVELY.

In part 2 of this podcast that will be published the following week, we will focus on pure Class I devices. Medical Device manufacturers should follow EU MDR 2017/745 from May 26th, 2020 and we are trying to help you understand the situation.

Who is Erik Vollebregt?

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A.

Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms.

He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.

Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

Links

• Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt/
• Axon Lawyer Website: https://www.axonlawyers.com/
• Slide Presentation: https://www.slideshare.net/ErikVollebregt/mdr-and-class-i-medical-devices-presentation-203092176
• Blog post on Corrigendum 2 (Erik Vollebregt): https://medicaldeviceslegal.com/2019/12/09/corrigendum-2-and-the-potential-consequences-for-class-i-devices/
• Corrigendum 2 link: https://data.consilium.europa.eu/doc/document/ST-13081-2019-INIT/en/pdf

The post Corrigendum 2 – Changes for Class I Devices with Erik Vollebregt (Part 1) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

The MDR Corrigendum 2 is changing the rules for some class I devices under MDD that are up classified under MDR. Let's see what manufacturers should do. The post Corrigendum 2 – Changes for Class I Devices with Erik Vollebregt (Part 1) appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/BBsykeqtUOg?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

This week we’ll start back with the basic steps to follow to evaluate your Medical Devices. It will seem basic for some people but you should not be so sure.

The new EU MDR 2017/745 is coming with many surprises and one of them is the fact that some products without a Medical purpose will now be considered as a Medical Device. So what you think is now changing.

With Heikki Pitkänen, we will explore 3 steps with you to evaluate your Medical Devices. It’S clearly mandatory for you to go through them.

• Step 1: Qualification of your Medical Device
• Step 2: Classification of your Medical Device
• Step 3: Best route to assess your Medical Device

After you followed those 3 steps, you are nearly sure to have a project built on a clear foundation.

In this episode, Heikki offers you access to his platform so you can evaluate your Medical Device and learn more about it. Don’t forget to download the giveaway which includes the promo code.

Who is Heikki Pitkänen?

Heikki is the CEO and founder of Lean Entries Ltd., a group of regulatory experts in the area of global medical device regulations providing unique digital regulatory services as well as traditional consulting for the MedTech sector from academies and startups to multinational enterprises.

Heikki has two decades of experience from medical device development, certification, accredited testing and standardization, most lately as the Notified Body site manager at SGS. He is a member of the CEN-CENELEC Advisory Board for Healthcare Standards.

Links

• Heikki Pitkänen Linkedin: https://www.linkedin.com/in/heikki-pitkänen-226b3b4/
• Len Entries Website: https://www.leanentries.com/
• Giveaway with Promo Code: https://mailchi.mp/easymedicaldevice/leanentries
• Podcast Episode 3: Is my product a Medical Device: https://podcast.easymedicaldevice.com/3/
• Qualify a Medical Device: https://easymedicaldevice.com/medical-device-definition/
• Classification of a Medical Device: https://easymedicaldevice.com/new-eu-medical-device-classification/

The post How to evaluate your Medical Devices in 3 Steps with Heikki Pitkänen? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

If you have a product and you want to evaluate if this is a Medical Device, then you need to follow the 3 steps that we will discuss on this episode. Heikki Pitkänen's platform is providing a solution for your to evaluate your device and he offers it for free to the listeners of this podcast. Thanks to him. The post How to evaluate your Medical Devices in 3 Steps with Heikki Pitkänen? appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/qVRKtw9DQSg?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The new Medical Device Regulation EU MDR 2017/745 and IVDR 2017/746 is providing some new vocabulary like “Economic Operators” and we will focus on one of them on this episode which is the Distributor.

The distributor has a particular responsibility within the new regulation. And this also means that some Distributors should update their Quality System or update some agreements they have with manufacturers.

Nicolaj Nitzsch is a Sales Manager at Scan-Med Norway and he is providing some support to understand what distributors should do to upgrade their system.

In this discussion, you will see that a lot of things were already in place for distributors before the new Medical Device Regulation, but with the MDR and IVDR, this should now be properly documented.

On the links below, I also included an article about another economic operator which is the European Authorized Representative.

Who is Nicolaj Nitzsch

With over 7 years of experience in the medical device filed where I over the years have developed a strong understanding of the importance of devices and the industry.

I have an education as a Data Technician Specializing in Infrastructure and have a strong mindset for business optimizing in the Nordic market.
I’m passionate about technology in general, Business Development and the industry of Medical and Health Tech because this is something that really can change the quality of life for patients.

Links

• Nicolaj Nitzsch LinkedIn: https://www.linkedin.com/in/nitzsch/
• ScanMed Norway: https://scan-med.com/
• Distributor Roles and Responsibility: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745#d1e2774-1-1
• Easy Medical Device Shop: https://school.easymedicaldevice.com/shop
• Economic Operator: European Authorized Representative: https://easymedicaldevice.com/ec-authorized-representative/

The post Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

What is the role of a Distributor within the new MDR 2017/745 and IVDR 2017/746. This is the question that I asked my guest who is working as distributor of Medical Devices in Norway. The post Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch appeared first on Medical Device made Easy Podcast.