If you are interested in learning more about whether to pursure FDA or EU pre-market approval first, take a moment to listen to my interview on Medsider. In the interview I discuss with host Scott Nelson a wide range of issues to consider.
Here’s an excerpt from Medsider about the interview:
It’s a constant debate. Pursue a medical device regulatory approval in the US? Or does it make more sense to seek a European approval first? Is there a definitive answer? According to Marc Sanchez, Founder of Contract In-House Counsel, medical device companies would be wise to take a step back and consider the business ramifications first.
In this interview with Marc, we learn more about this hotly debated issue as well as a host of other interesting medical device regulatory trends. Okay, so who is Marc Sanchez? He’s the Founder of Contract In-House Counsel and Consultants. His law practice focuses on building a regulatory strategy for start-ups and small to midsize companies in the medical device field. This strategy includes both pre-market approval and post-market surveillance matters.
Read more at medsider.com or listen above.
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