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How to register a Medical Device with FDA? (510k, PMA, de Novo…)

We will certainly speak about the item category, the various enrollment treatments (510k, deNovo, PMA) as well as likewise concerning the Quality Management System appropriate by the FDA.

► Website:

To aid us, I welcomed Michelle Lott from LeanRAQA. When you are attempting to sign up a Medical Device in the USA, she will certainly allow you recognize what are the various actions to think about.

After paying attention to this episode, you will certainly have a minimal understanding to put your item to the United States market. Anyhow if you require assistance you can call Michelle or me to address your inquiries.

The obstacle for Medical Device firms is to comprehend the various paths to register their items in a specific area. On this episode, we will certainly concentrate on the United States FDA guideline for Medical tools.

► Who is Michelle Lott

Michelle Lott is creator and also principal of leanRAQA, which has actually sustained 100+ firms with governing method, governing entries, top quality systems conformity, FDA audits, due persistance, technological assistance solutions– (and also despair therapy, since taking care of regulatory authorities can be psychologically draining pipes!).

She has actually offered on the FDA Device Good Manufacturing Practices Advisory Committee and also is a singing supporter of EU MDR preparedness. Michelle offers the clinical gadget, nutritional supplements, biologics, pharmaceutical, cosmetics, and also food markets. She has a weak point for tequila and also anything grilled.

#FDA #medicaldevice #compliance

► Links
■ Michelle Lott Linkedin:
■ LeanRAQA web site:
■ Episode Unannounced Audit:
■ Article “510k Substantial Equivalence”:

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■ Instagram:

► Social Media to comply with