Manage episode 285616561 series 1017311
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.”