Hardware Podcasts

031 - "The Five Stages Of Regulatory Grief" with Michelle Lott

Let's Combinate · 4 May 2022 · 1h 19m

What this episode covers

Michelle Lott, founder of Lean RAQA, discusses her journey from large manufacturer Baxter Healthcare to consulting for small-to-mid-size medical device companies, highlighting the gap in practical regulatory strategy. She details the 'five stages of regulatory grief' clients experience when facing FDA interactions, contrasting the US 510(k) process with the rigorous, ongoing costs of EU MDR compliance. Lott also explains the nuances of regulations versus guidance documents, the QMSR harmonization, and her unique perspective as an elected industry representative on the FDA Device GMP Advisory Committee.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Lean RAQA, Baxter Healthcare, FDA
Also
EU MDR, ISO 13485, QMSR, 510(k), Form 483

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