Are You Required to Have a 13 Forty Five Certificate?

In the new c s m r world, you're not required to have a 13 forty five certificate. I do think many of these folks will still be playing in international markets if they don't get one. But that is not something that i'm seeing in the proposed rule that's driving that time difference into so much asjus conditions that industry's facing.

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FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the international standard for medical device quality management systems. How will, what's being referred to as Quality Management System Regulation (QMSR), affect the medical device industry and regulatory bodies?

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences and George Zack of Two Harbors Consulting about the changes unfolding and the pros and cons of harmonization between QSR and ISO 13485:2016—a standard not governed by FDA.

Some of the highlights of this episode include:

The FDA is not expected to adopt ISO 13485 or any other standards across the board. Instead, it will take a piecemeal approach. Any future revisions to the 2016 version of the standard would need to be evaluated before becoming part of U.S. regulations.
How often are periodic changes and updates made to QSR, ISO standards, and FDA guidances? Do changes even need to be made or are they a waste of time and money? Good regulation is agnostic of time and technology.
Government bodies in different parts of the world want to protect their citizens. Will there ever be global harmonization for quality? Are the most important principles of quality a function of geography? No, quality is quality.
The timeline to transition is one year, but companies and inspectors may need or want more time due to a limited number of resources and notified bodies.
If a company does what it should do for the safety and efficacy of medical devices, it should really be a tiny or no leap at all to make changes. The only changes are in the paperwork and forms.
Medical device professionals should know about ISO 13485. If they do not know about this standard, whether it is required or not, that could be a problem.
For those adhering to ISO 13485, if there are new requirements that make sense from a biology and engineering perspective, that’s the way to do something.

Memorable quotes from this episode:

“They are not going to adopt ISO or any other standards across the board. They’ll take sort of a piecemeal approach, and I think that makes sense.” Mike Drues

“When was the last time that the design control guidance was updated since it was created in 1997? The answer is, never. That guidance has remained exactly the same.” Mike Drues

“Good regulation is timeless.” George Zack

“While it might not be a huge shift, I think it is a step in a direction of many steps toward some sort of global harmonization.” George Zack