How to register a Medical Device through FDA 510k with Michelle Lott

► Webpage: podcast.easymedicaldevice.com/58
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. Check on the links below.
We will discuss the different types that are existing:
■ Traditional 510k
■ Abbreviated 510k
■ Special 510k
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.
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► 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.
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► Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses...
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► Links from the Video
­■ Michelle Lott Linkedin: / michellelottraqa
■ LeanRAQA website: leanraqa.com/
■ Download 510k Presentation: mailchi.mp/easymedicaldevice/...
■ MDG Premium website: www.medicaldevicesgroup.net/p...
■ FDA 510k process: www.fda.gov/medical-devices/p...
■ Substantial equivalence blog post: easymedicaldevice.com/substan...
■ Episode 43 - FDA Registration: podcast.easymedicaldevice.com...
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► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#medtech #medicaldevice #compliance

[@ghulammohyuddinbhatti3292]

Thanks Sir Monir and Michelle Lott for detailed information regarding Registration of Medical Devices in US FDA as 510k.

[@cute_ink]

I am a RA specialist in South Korea. I love your every video! Thank you indeed :)

[@EasyMedicalDevice]

Thanks for your comment. Really happy that you like the content. Let me know if there is a specific topic that you want to hear about.

[@NoumanAhmadKhan]

I want to sell surgical face mask. Can you help me out. What i need to do with fda to sell product

[@EasyMedicalDevice]

Hi, FDA has an EUA process. I recommend you to discuss with Michelle Lott about this. She may be able to help you. I had her on a podcast for product registration in the US.

[@NoumanAhmadKhan]

Thanku for you response . Can you plz guide me how to contact michelle

[@EasyMedicalDevice]

Nouman Khan she is available on LinkedIn. Her details are on my previous podcast episode with her in January 2020

[@NoumanAhmadKhan]

Thanku! Ill try to contact her.