How to register your Medical Device through 510k with Michelle Lott
510k is a famous way to register your Medical Devices in the US. It is so famous that even if you don’t need it, you will ask to go through it. In this episode, Michelle Lott, Founder, and Principal at LeanRAQA will help us understand everything about 510k. And she is also providing a Slide deck to help you understand all about the FDA process.
We will discuss the different types that are existing:
We will also discuss the way to use standards to confirm that your product conforms to the regulation. Similar to the Harmonized Standards used in Europe.
On a different note, Michelle will explain to the audience participation in the MDG Premium. This is a group where Medical Device experts, manufacturers, service providers are part of.
Who is Michelle Lott
Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!).
She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries.
She has a weakness for tequila and anything barbecued.
Links for this episode
- Michelle Lott Linkedin: https://www.linkedin.com/in/michellelottraqa/
- LeanRAQA website: https://leanraqa.com/
- Download 510k Presentation: https://mailchi.mp/easymedicaldevice/510k-presentation
- MDG Premium website: https://www.medicaldevicesgroup.net/premium/
- FDA 510k process: https://www.fda.gov/medical-devices/premarket-notification-510k/510k-forms
- Substantial equivalence blog post: https://easymedicaldevice.com/substantial-equivalence-on-a-fda-510k-process-how-to-demonstrate-it/
- Episode 43 – FDA Registration: https://podcast.easymedicaldevice.com/43/