Description

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the FDA’s recently implemented QMSR. It went into effect on February 2nd and replaced 21 CFR Part 820. The regulation incorporates ISO 13485:2016, which is expected to help align medical device regulations globally. In this podcast, we focus on what device manufacturers should be doing now and what can wait for a later time. During this conversation, the following questions are addressed:

• As most are already familiar with QMS and now QMSR, we’ll dive deeper. Can you tell me if all sections of the QMSR listed in the QSR are required for all medical devices?
• Is a full QMS required to be in place in order to secure FDA clearance or approval?
• What about the sections of the QMSR? Are all of them equal in terms of importance? Are some sections more important than others?
• When do I need to have a QMS in place?
• What if I never intend to market my device? First, maybe provide an example of when that would be the case, and then address the first part.
• Should all QMS systems look the same?
• Are there differences with the QMSR with premarket vs. postmarket?
• How do you know the QMS is working? How can you be sure?
• What are the important takeaways from today’s session?

Listen to this discussion and see if you are compliant with the new QMSR. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com, and we’ll see if your ideas/inquiries/suggestions align with a future episode.

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