Description

In today’s episode, Shawnnah Monterrey discusses the 3P510k - which is short for the 510k 3rd Party Review Program. This is a lesser known program, but there can be significant benefits from using it, which we talk about during the episode.

Some of the issues we discussed include:

How utilizing this program can accelerate the submission process, or at least remove some uncertainty around the timeline
Who this program is for - not just for small startups, but rather how even experienced Regulatory Affairs specialists working at large corporations can benefit from this program.
Lastly, we don’t usually get into the specifics of cost and expenses, but we even discuss some of the differences in how much you’ll pay using the 3P510k route vs. the traditional submission route.

Shawnnah Monterrey is the founder of BeanStock Ventures after nearly a 20-year career as a technical leader. Shawnnah was responsible for developing strategies and leading complex global product development programs and functional management of software and software quality assurance departments for both startup and mature organization with emphasis on the development of medical instruments, life science, diagnostics, clinical applications.

Reference Links:

#330: 3P510k: What Is a 510k 3rd Party Review, and What are the Benefits?

Global Medical Device Podcast powered by Greenlight Guru

#330: 3P510k: What Is a 510k 3rd Party Review, and What are the Benefits?