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Do you understand the difference between significant risk and nonsignificant risk when it comes to the development and design of your medical devices?

 It’s important to classify devices properly, and the difference between SR and NSR is not always well-defined.

 

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Today, our guest will help medical device companies differentiate between these two classifications.

Mike Drues, president of Vascular Sciences, has been a frequent guest on our show. He’s an expert in compliance, medical technology and regulatory compliances.

Mike works regularly with the FDA, Canada Health, and other international regulatory agencies, and today he is sharing his insight on SR vs. NSR, as well as how this affects your development processes for your medical devices.

Some of the topics you’ll hear about today include:

  • The difference between significant and nonsignificant risk, and how you can differentiate between the two.
  • Who decides whether a device has a significant or nonsignificant risk. (Hint: It’s not the FDA!)
  • Tips on analyzing, documenting, and finding experts to help you determine whether you are dealing with SR and NSR, as well as tips on notifying the FDA through the pre-submission process.
  • Information about the Institutional Review Board and how they are involved in the SR vs. NSR differentiation.
  • Thoughts on running clinical trials outside of the USA: advantages, disadvantages, and practicalities.

Additional Links: 

Device Regulation Guidance

Significant Risk and Nonsignificant Risk
Medical Device Studies FDA Guidance

Mike on LinkedIn

Vascular Sciences 

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Quotes:

Our goal should not be to avoid the FDA; our goal should be to work with them.

In many cases, there aren’t devices that are the same... at the end of the day, it’s our determination.

Ask yourself if you’d feel comfortable using a clinical device on a family member, a friend, or yourself... we are talking about people’s lives here.


About The Global Medical Device Podcast:
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The Global Medical Device Podcast powered by greenlight.guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or SoundCloud.