https://www.youtube.com/embed/goY0i8fmcNY?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

In this second episode on System and Procedure Pack, we answer more questions about this way to place devices on the market. Erik got some experience with the authorities that he will share with us and I have created some cases that I will propose to Erik and see how he would manage them. Erik will also talk more about IVDR as this is a topic of high importance. Erik will also tell us more about his book. Follow the links for more details.

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.”

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companies 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, podcasts, Online courses…

• Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/

The post System and Procedure Pack the RETURN with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/1RsFhuir0TY?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

We received the First Expert Panel Opinion and by reading it you can say a lot. So to help us have a good interpretation of it, I have asked Bassil Akra to be my guest on this podcast episode.

We will remind you what is the Expert Panel, then we’ll discuss more deeply the Opinion received and finally, we will provide you some advice on how to avoid certain issues when you have to go through this process.

If you want to get this document, you have the link below.

Dr. Bassil Akra, CEO of Akra Team has a background in research, development, regulatory approval, and quality management of medical devices. Within his role at TÜV SÜD, Dr. Akra was a member of various Medical Device Regulation (MDR) European task forces, to help with the interpretation of the new legislation towards a smooth transition into May of 2020. In addition to his work as a senior field expert for TÜV SÜD, Dr. Akra presents worldwide on the European requirements and was involved in the development of many guidance documents and standards.

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companies 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…

• Akra team website: https://www.akrateam.com

The post How to interpret the first Expert Panel Opinion? [Bassil Akra] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/hpn7PDIYD_s?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

In this episode of the podcast, we will provide an update on the Medical Device industry for the period June July 2021.

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companies 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…

• Joint implementation and preparedness plan for Regulation MDR 2017/745 on IVDR: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_joint-impl-plan_en.pdf

The post Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/TgSIZJ9OxIE?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

State-of-the Art is an important topic but not well understood. It’s why I have invited Hakan Inan from Requalite to help us get a better understanding of this concept that you should use on your Clinical Evaluation or Performance Evaluation. We will talk not only about MDR but also about IVDR as this concept is required for both. Don’t hesitate to go on the show notes to see the documents that can help you with that.

Hakan Inan is the founder and the managing director of Requalite GmbH, Medical device compliance consulting company, with a special focus on Medical writing activities for Performance and clinical evaluation reports as per MDR and IVDR. Hakan holds a PhD in Nanotechnology and has developed in vitro diagnostic devices for cancer applications at Medicine Faculty-Stanford University. Requalite provides support to Medical device and In vitro diagnostic device companies in their compliance journey by designing and creating Performance and Clinical Evaluation Reports. Requalite has a strong team of experts, all with PhD degrees in the scientific fields including immunology, hematology, oncology, neurology, and cardiovascular diseases, etc.

Monir El Azzouzi is a Medical Device Expert Specialised in Quality and Regulatory Affairs. He decided to quit his corporate job to start EASY MEDICAL DEVICE. He is now providing support to the Medical Device industry by educating people with his Blog, Podcast, Youtube channel and also helping them through consulting, coaching, and training. He decided to open an office in the UK to be able to support his customers that would need a UK Responsible Person. Easy Medical Device is becoming the one-stop-shop for Medical Device Industry.

• Requalite Website: www.requalite.com

The post How to build your State-of-the-art for your Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/yUXFXfV7lgQ?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

In this episode of the podcast, I wanted an expert to answer the question about IP related to Medical Devices. A lot of people are willing to understand how intellectual property works when for example:

• We have a Private Labeling Business

Stephan Carter from UK is my guest today and he manages this type of situation for you. You will hear on this episode some advice that would really be beneficial to your business.

Stephen is a UK and European patent attorney and founder of The Intellectual Property Works. He is recognized by ‘IAM Strategy 300’ as one of the world’s leading IP strategists and is now focused on working with ambitious MedTech start-ups and SMEs to protect their innovations, helping them to succeed so they can make a positive impact in the world.

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companies 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…

• Stephen Carter LinkedIn Profile: https://www.linkedin.com/in/stephenjcarter/

The post How Intellectual Property is linked to the Medical Device Regulation? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi