Register your Medical Device in the US with Michelle Lott (FDA)
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The challenge for Medical Device companies is to understand the different pathways to register their products in a certain region. On this episode, we will focus on the US FDA regulation for Medical devices.
To help us, I invited Michelle Lott from LeanRAQA. She will let you know what are the different steps to consider when you are trying to register a Medical Device in the USA.
We will talk about the product classification, the different registration procedures (510k, deNovo, PMA) and also about the Quality Management System acceptable by the FDA.
After listening to this episode, you will have a minimum understanding to place your product to the US market. But anyway if you need support you can contact Michelle or me to answer your questions.
Who is Michelle Lott
Michelle Lott is 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
- Michelle Lott Linkedin: https://www.linkedin.com/in/michellelottraqa/
- LeanRAQA website: https://LeanRAQA.com
- Episode Unannounced Audit: https://podcast.easymedicaldevice.com/17
- Article “510k Substantial Equivalence”: https://easymedicaldevice.com/substantial-equivalence-on-a-fda-510k-process-how-to-demonstrate-it/
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