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The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an on-demand recording from May, 2022
While MDR does not define state of the art, it discusses state of the art in eleven instances. Further, though MEDDEV 2.7.1/4 also does not define the term, the guidance discusses state of the art 39 times.
Unlike MDR, ISO 14971:2019 did formally define state of the art. This webcast will discuss how this definition further rolls into the definition of standard of care.
The presentation will also cover how this definition in context of the formal MDR and MEDDEV references impacts technical documentation, risk analysis, clinical, and postmarket documentation.
This webcast is best suited for regulatory professionals involved in the preparation of documentation throughout the product lifecycle from early design and development to postmarket surveillance and ongoing risk management activities. These concepts will have a far-reaching impact on the proper content of these living documents.
Michelle Lott is founder and principal of leanRAQA (leanraqa.com). She and her team supported over a hundred 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.
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