Easy Medical Device Podcast

https://www.youtube.com/embed/NHjA--on8V0?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

We continue on this series about Economic Operators and this time we will let you understand what they should check. What an Importer, Distributor or Authorized Representative should check before placing your product on the market.

Erik Vollebregt from Axon Lawyers will help us to interpret the regulation as many peoples are asking some questions regarding sampling checks or about the level of details to review some elements. So don’t miss this series which will provide you with all the details.

Don’t hesitate also to go to the link section to check the Agreement Templates that I created on Economic Operators. They were reviewed specifically to match the MDR and IVDR requirements.

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.”

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links from the Video

• Erik Vollebregt LinkedIn: https://www.linkedin.com/in/erikvollebregt/
• Erik Vollebregt Presentation: https://www.slideshare.net/ErikVollebregt/managing-new-requirement-for-economic-operator-regime
• HPRA – Guide for Distributors of Medical Devices: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/ia-g0004-guide-for-distributors-of-medical-devices-v1.pdf?sfvrsn=13
• Easy Medical Device Shop (Download Economic Operators Agreement Templates): https://easymedicaldevice.com/shop/
• RAPS Focus. Economic Operators: Roles and Obligations under EU’s MDR: https://www.raps.org/news-and-articles/news-articles/2020/2/economic-operators-roles-and-obligations-under-eu
• Medtech Europe Flowchart MDR: https://www.medtecheurope.org/wp-content/uploads/2018/01/EN_MTE_MDR_Flowchart_Dec2017.pdf

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

The post Medical Device School: What should verify your Economic Operators? 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.

Your Economic Operators do have some responsibility per EU MDR and IVDR. What should they check? Monir El Azzouzi and Erik Vollebregt will help you understand that on this bonus episode. The post Medical Device School: What should verify your Economic Operators? appeared first on Medical Device made Easy Podcast.

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

We talked a lot about how to perform a Clinical Evaluation for your medical device. But when your device has a low risk and there is not enough data to prove safety, how then it is possible to show that you have enough data to place your device on the market. Robert van Boxtel from MD Project will help us define what can be done as there is always a solution. Robert will help you with some suggestions on how you can collect data that you already have as preclinical data or will help you find some information regarding other devices. What is also interesting is to talk about clinical data with products that are not touching the patients at all. We will also clarify that. Don’t forget to download the presentation that Robert prepared about this topic.

Who is Robert van Boxtel?

Robert van Boxtel graduated in the field of biomedical materials from the University of Twente in the Netherlands (MSc).

For eight years he worked in the medical device industry in the Netherlands and USA, in different roles within R&D and manufacturing. In 2003 he started at Notified Body KEMA Quality B.V., currently known as Dekra Certification. In his job as Sr. Project Manager Certification Medical Devices, Robert van Boxtel worked around the globe to assess medical devices on safety and performance, and audit the QMS’s of medical device manufacturers.

As a result, he developed an in-depth knowledge of CE regulations and ISO 13485. In addition to that, he was responsible for international large accounts and the FDA 3rd party review program, in which KEMA (Dekra) was participating at the time. During the last 9 years, as Principal Consultant at Medical Device Project B.V. in the Netherlands, he is assisting medical device manufacturers with their QMS, technical files, and regulatory submissions.

In addition to that, he is hired by the Dutch Norm Institute (Royal NEN), as SME for teaching on ISO 13485 and MDD/MDR. Furthermore, he participates in TC210 discussions on risk management, ISO 13485 and PMS. As a result, he has 25 years of experience in the medical device industry.

His expertise’s are:

• EU medical device regulations (MDR/IVDR)
• ISO 13485:2016
• Risk management (including animal tissue)
• Clinical evaluation;
• PMS;
• QMS development/improvement;
• Troubleshooting; Product-, equipment- and process validation;
• Participating in / leading development projects;
• Building Regulatory submission files (EU and USA);
• Lead Auditor.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.

He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links

• Robert van Boxtel LinkedIn: https://www.linkedin.com/in/robert-van-boxtel-a056676/
• MD Project website: https://www.mdproject.nl/
• MD Project LinkedIn: https://www.linkedin.com/in/medical-device-project-b-v-8b5a4569/
• Download presentation: https://mailchi.mp/easymedicaldevice/low-risk-device-clinical-data

The post Clinical Data for Low Risk Medical Devices with Robert van Boxtel 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.

Many medical device manufacturers try to solve a puzzle regarding their Low risk medical devices. How to write Clinical Evaluation for it without data? here is the solution. Download the presentation. The post Clinical Data for Low Risk Medical Devices with Robert van Boxtel appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/6VEG05xiaYM?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

In this Medical Device School Bonus episode, Erik Vollebregt and Monir El Azzouzi are helping you to understand the way the Economic Operators are controlled.

A Manufacturer can be controlled for example by a Notified Body. But what about a Distributor, Importer or Authorized Representative? You’ll know everything about it in less than 10 minutes.

Economic Operators need to create agreements between them to be sure that they are working in collaboration. Check the templates provided in the shop. They were updated to meet the EU MDR and IVDR requirements.

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.”

Who is Monir El Azzouzi

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Link

• Monir El Azzouzi LinkedIn: https://www.linkedin.com/in/melazzouzi/
• Erik Vollebregt LinkedIn: https://www.linkedin.com/in/erikvollebregt/
• Erik Vollebregt Presentation: https://www.slideshare.net/ErikVollebregt/managing-new-requirement-for-economic-operator-regime
• HPRA – Guide for Distributors of Medical Devices: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/ia-g0004-guide-for-distributors-of-medical-devices-v1.pdf?sfvrsn=13
• Easy Medical Device Shop (Download Economic Operators Agreement Templates): https://easymedicaldevice.com/shop/

The post Medical Device School – Who controls your Economic Operators? 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.

In this episode we will explain you the way that Economic Operators are controlled. This may seem obvious but the answer can be different per Economic Operator. So listen to this short episode of Medical Device School to understand everything. The post Medical Device School – Who controls your Economic Operators? appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/ym2bQoe620s?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Alert: Too much -xit will be mentioned in this episode of the Podcast. We apologize if some confusion happens.

Monir El Azzouzi and Erik Vollebregt will help you understand the situation in the United Kingdom with Brexit, talk a bit of the Switzerland situation or Swixit and then finish with the situation in Turkey called Turkxit.

Brexit: Since February 1st, 2020 Brexit is live. So what are the consequences for the medical device manufacturers? What should they do now?

Swixit: We discussed during the last episode about Swixit with Ronald Boumans. Erik did talk about it to compare its situation to Brexit or other countries.

Turkxit: Turkey does have the same situation as Switzerland now. But the process seems less transparent. If some people can give us some feedback it would be great.

We hope that there will be no other XIT that will happen as we are stronger together.

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.”

Who is Monir El Azzouzi

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links

• Erik Vollebregt LinkedIn: https://www.linkedin.com/in/erikvollebregt/
• Monir El Azzouzi Linkedin: https://www.linkedin.com/in/melazzouzi/
• Axon Lawyers Website: https://www.axonlawyers.com/
• Erik Vollebregt Blog post: https://medicaldeviceslegal.com/2020/01/30/brexit-is-a-fact-now-deal-with-it/
• Episode 62 – Swixit or not Swixit?: https://podcast.easymedicaldevice.com/62/

The post Are Brexit, Swixit, and Turkxit a reality? with Erik Vollebregt 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.

Brexit, Swixit, Turkxit. These are the topics of this episode of the Podcast. We will try to help you understand all these -XIT and what is the impact to Medical Device manufacturers. The post Are Brexit, Swixit, and Turkxit a reality? with Erik Vollebregt appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/O1Ol3udZeII?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

With MDR 2017/745 and IVDR 2017/746, we discover some new Vocabulary and one of them is clearly important to consider and this is “Economic Operators”.

Monir El Azzouzi and Erik Vollebregt will help you define who are your Economic Operators and also if you are still not sure, how to identify them.

Don’t forget to download the presentations and documents provided in the link section.

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.”

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.

After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.

He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links

• Monir El Azzouzi LinkedIn: https://www.linkedin.com/in/melazzouzi/
• Erik Vollebregt LinkedIn: https://www.linkedin.com/in/erikvollebregt/
• Erik Vollebregt Presentation: https://www.slideshare.net/ErikVollebregt/managing-new-requirement-for-economic-operator-regime
• HPRA – Guide for Distributors of Medical Devices: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/ia-g0004-guide-for-distributors-of-medical-devices-v1.pdf?sfvrsn=13
• Easy Medical Device Shop (Download Economic Operators Agreement Templates): https://easymedicaldevice.com/shop/

The post Medical Device School – Who are your Economic Operators? 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.

Who are the Economic Operators mentioned on the MDR and IVDR? This is the question that Monir El Azzouzi and Erik Vollebregt will try to answer. The post Medical Device School – Who are your Economic Operators? appeared first on Medical Device made Easy Podcast.