Home Events The basics on FDA and Medical Devices

20 februari 2020, 13:30 - 15:30 uur

The basics on FDA and Medical Devices

Briskr Academy workshop

An entry level overview to the FDA

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, including timeline and general cost ranges
  • What to expect in terms of enforcement & inspections from FDA
  • And how to manage for compliance
Presenter Michelle Lot: Regulatory Strategist, Principal and Founder of Lean RAQA is a 20-year regulatory and quality professional and earned her Regulatory Affairs Professionals Society certification from 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.
Novio Tech Campus, gebouw M, SMB Meet&Greet, Transistorweg 5, 6534 AT Nijmegen
Michelle Lot


Novio Tech Campus, gebouw M, SMB Meet&Greet
Transistorweg 5
6534 AT Nijmegen

Health Valley Partners