Insights & News

Project MedTech: The Overlap of Regulatory Strategy And Business Strategy with Isabella Schmitt

January 25, 2022
MedTech
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Compliance & Regulatory: MedTech
In Project MedTech's podcast hosted by Duane Marcini, Isabella discusses M1 Accelerator, the importance of regulatory strategy, why startups shouldn’t be afraid of a PMA & much more!

Proxima CRO has grown a lot over COVID-19 pandemic,  Proxima is proud to be a sponsor of M1 MedTech Accelerator, and startups navigating regulatory strategy (as always) can be very challenging - Isabella Schmitt, a leader at Proxima CRO, is ingrained in all these stories.

In this episode of the Project MedTech's Podcast, Duane Marcini talks to Isabella Schmitt, Director of Regulatory Affairs for Proxima Clinical Research (CRO).

Together, Isabella and Duane discuss the best ways to implement regulatory strategy into your business and common MedTech and biotech startup mistakes Isabella hopes companies can avoid.

Tune in, here!

Some of the Highlights of the Show Include:

  • Isabella Schmitt, Proxima CRO's Director of Regulatory Affairs and Duane Mancini discuss the rapid growth Proxima has seen in the last 5 years, the new accelerator she founded called M1 Accelerator, the importance of regulatory strategy, why one might choose a de novo vs. 510k, why startups shouldn’t be afraid of a PMA, implementing regulatory strategy into your business strategy, the common mistakes Isabella sees with startups, her best advice for startups and so much more.

Listen here!

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