Artwork

Greenlight Guru + Medical Device Entrepreneurs에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Greenlight Guru + Medical Device Entrepreneurs 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
Player FM -팟 캐스트 앱
Player FM 앱으로 오프라인으로 전환하세요!

How does EU MDR impact your Quality Management System?

36:06
 
공유
 

Manage episode 285616561 series 1017311
Greenlight Guru + Medical Device Entrepreneurs에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Greenlight Guru + Medical Device Entrepreneurs 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.

The new medical device regulation in the European Union (EU MDR) has introduced a host of new challenges for medical device companies. One challenge, in particular, has to do with the quality management system of a medical device.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Monir El Azzouzi, founder and CEO of Easy Medical Device. Also, Monir is a prolific podcaster, blogger, and YouTuber that helps medical device companies achieve compliance.

Together, Monir and Jon discuss the ways in which EU MDR impacts a quality management system and best practices medical device companies can follow to maintain compliance with new requirements.

Some highlights from this episode include:

  • Medical device manufacturers have several QMS standards, regulations, and frameworks to follow, such as ISO 9001, ISO 13485, and FDA 21 CFR Part 820.
  • Rumor has it that the FDA is harmonizing its Quality System Regulation (QSR) with ISO 13485:2016. Why? FDA’s QSR and ISO 13485:2016 offer significant similarities toward harmonization depending on where medical device companies, manufacturers, and products are located (in the United States or European Union).
  • EU MDR implementation involves a complex transition process, it’s not about simply updating a technical file.
  • What are the differences between ISO 13485:2016 and EU MDR? Refer to Article 10.9 for process requirements and Easy Medical Device courses.
  • Research notified bodies to determine and verify authenticity, authorization, and accreditation.
  • QMS changes related to EU MDR place greater emphasis on clinical and post-market surveillance as well as risk/benefit management. Be proactive!
  • When everything goes well, nobody rechecks what you are doing. As soon as there is an issue on the market or there is a competitor that may want to raise some concerns, then the authorities can come and visit your site.
  • EU MDR: Will it be delayed or postponed again due to COVID, remote audits, or because it’s too difficult to implement? MDR is a chance to level up and raise the bar in the medical device world.

Memorable quotes from Monir El Azzouzi:

“A quality management system is not just a bunch of documents.”

“When you are, for example, manufacturing some medical devices, you have to respect some rules, some regulations.”

“Don’t pay something twice (choose certification vs. notified bodies wisely).”

“EU MDR is a regulation that is...raising the bar in terms of requirements and things that you need.”

“When everything goes well, nobody will recheck what you are doing. But as soon as there is an issue on the market, as soon as there is a competitor that maybe wants to raise some concerns, then the authorities can come and visit your site.”

  continue reading

430 에피소드

Artwork
icon공유
 
Manage episode 285616561 series 1017311
Greenlight Guru + Medical Device Entrepreneurs에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Greenlight Guru + Medical Device Entrepreneurs 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.

The new medical device regulation in the European Union (EU MDR) has introduced a host of new challenges for medical device companies. One challenge, in particular, has to do with the quality management system of a medical device.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Monir El Azzouzi, founder and CEO of Easy Medical Device. Also, Monir is a prolific podcaster, blogger, and YouTuber that helps medical device companies achieve compliance.

Together, Monir and Jon discuss the ways in which EU MDR impacts a quality management system and best practices medical device companies can follow to maintain compliance with new requirements.

Some highlights from this episode include:

  • Medical device manufacturers have several QMS standards, regulations, and frameworks to follow, such as ISO 9001, ISO 13485, and FDA 21 CFR Part 820.
  • Rumor has it that the FDA is harmonizing its Quality System Regulation (QSR) with ISO 13485:2016. Why? FDA’s QSR and ISO 13485:2016 offer significant similarities toward harmonization depending on where medical device companies, manufacturers, and products are located (in the United States or European Union).
  • EU MDR implementation involves a complex transition process, it’s not about simply updating a technical file.
  • What are the differences between ISO 13485:2016 and EU MDR? Refer to Article 10.9 for process requirements and Easy Medical Device courses.
  • Research notified bodies to determine and verify authenticity, authorization, and accreditation.
  • QMS changes related to EU MDR place greater emphasis on clinical and post-market surveillance as well as risk/benefit management. Be proactive!
  • When everything goes well, nobody rechecks what you are doing. As soon as there is an issue on the market or there is a competitor that may want to raise some concerns, then the authorities can come and visit your site.
  • EU MDR: Will it be delayed or postponed again due to COVID, remote audits, or because it’s too difficult to implement? MDR is a chance to level up and raise the bar in the medical device world.

Memorable quotes from Monir El Azzouzi:

“A quality management system is not just a bunch of documents.”

“When you are, for example, manufacturing some medical devices, you have to respect some rules, some regulations.”

“Don’t pay something twice (choose certification vs. notified bodies wisely).”

“EU MDR is a regulation that is...raising the bar in terms of requirements and things that you need.”

“When everything goes well, nobody will recheck what you are doing. But as soon as there is an issue on the market, as soon as there is a competitor that maybe wants to raise some concerns, then the authorities can come and visit your site.”

  continue reading

430 에피소드

모든 에피소드

×
 
Loading …

플레이어 FM에 오신것을 환영합니다!

플레이어 FM은 웹에서 고품질 팟캐스트를 검색하여 지금 바로 즐길 수 있도록 합니다. 최고의 팟캐스트 앱이며 Android, iPhone 및 웹에서도 작동합니다. 장치 간 구독 동기화를 위해 가입하세요.

 

빠른 참조 가이드