This workshop will cover everything from identifying if your product is even considered a device, to understanding requirements, exemptions, costs, and timelines.The attendees will leave with knowledge on:
– The likely classification and regulatory pathway and how to verify this
– Steps to submission and to market, incl. timeline & general cost ranges
– What to expect in terms of enforcement & inspections from FDA
– And how to manage for compliance
Presenter Michelle Lott
(Regulatory Strategist, Principal and Founder of Lean RAQA) is a 20-year regulatory and quality professional and attended the RAPS Executive Leadership Program at Northwestern’s Kellogg School of Management. She has corporate experience with manufacturers including Baxter Health Care and served a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee (DGMP).
Since 2010, Michelle’s company, Lean RAQA
, has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services, and grief counseling – because dealing with regulators can be emotionally draining. Her clients delegate all those things to her, so they can focus on winning.
The workshop is facilitated in English and is free of charge
This workshop is powered by Briskr Validate! – a project funded by EFRO (European Fund for Regional Development)
Bookings are closed for this event.
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