FDA Regulations and Medical Device Pathways to Market

FDA Regulations and Medical Device Pathways to Market

Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.

In this presentation, we cover important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.

There are a lot of regulatory requirements and any misstep could cause costly delays.

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