Mike Drues is one of the most gifted regulatory people I know. At 10x he said,

If you’re going to change a medical device in an administrative way, you have two options to handle that.
• You notify the FDA (and if you do, how?); or,
• You don’t notify the FDA.

He and Jon Speer took us down the letter-to-file path, and the pros + cons of each in this great discussion (with transcript).

I really learned a lot from this one.

You will, too – and please this article with your network.

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Michael and Jon return to 10x in May

My expert friends Mike and Jon will host a three-hour workshop in San Diego on May 14 (the day before the conference begins). Join us!

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New Jobs Posted – Want One?

If you’re looking for work, we added new jobs this week here!

We are showcasing these three for immediate hire:

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On our Discussion Board

• Elizabeth is looking for MDR-compliant EU-authorised reps for small medical device manufacturers.

• Roger asks, “Should early biotechs buy bioreactors or use a contract manufacturer?“

• With Brexit approaching, Alison is warning about an impending disaster for slow-to-act medical device medical device manufacturers.

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Thank you for being part of our Medical Devices Group community!

Please this article if your network will benefit.

Joe Hage
Founding Principal,
Medical Devices Advisory Group

P.S. As more and more guests register for 10x, the value goes up for everyone who attends. Download the brochure, you’ll see.