Resource Center

Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.

Third-Party Review of 510(k)s

Third-Party Review of 510(k)s

FDA is not the only organization that can review 510(k) submissions. Under the Third Party (“3P”) Review Program, ...
Your 2019 Wish List!

Your 2019 Wish List!

We witnessed several changes in the medical device industry in the year 2018. The impact of some changes was ...
Medical Device Manufacturing and Product Quality

Medical Device Manufacturing and Product Quality

The purpose of this webinar is to discuss the FDA’s voluntary medical device manufacturing and product quality pilot program, CMMI Institute’s role in it and how manufacturers will benefit from this program.
FDA’s  510(k)  Pilot  Programs

FDA’s 510(k) Pilot Programs

The FDA’s 510(k) process for medical devices is doing a lot of rounds in the news lately. This includes the FDA ...

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