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ASQ: Split Personalities of QMS under FDA QSR, ISO 13485 and MDSAP
March 30, 2022 @ 6:30 pm - 7:30 pm
(Bilingual Q&A Bilingue)
30 March 2022 19:00
Networking Opportunity 18:30
Trying to maintain compliance under FDA QSR, ISO 13485, and MDSAP can leave a company with a QMS identity crisis.
This webinar will discuss strategies to manage regulations, risks, and audits in the medical device industry for the US & Canada. Specifically, we will explore differences in ISO 13485, FDA, and MDSAP audits and the impact on audit management and the structure of the quality management system.
About our speaker: Michelle Lott, is a principal and founder of leanRAQ. She 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 those things to her, so they can focus on winning in the marketplace. Michelle served a four-year term on the FDA Device Good Manufacturing Practices Advisory Committee (DGMP), holds a BS in Chemistry from Troy State University and is a Certified Executive Leader in Regulatory Affairs from RAPS and Kellogg University.