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Medical Device Voluntary Malfunction Disclosure Regulation: Are You Up to Date on the Latest Developments?
The Voluntary Malfunction Summary Reporting Program was finalized in August 2018 and lets manufacturers report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis instead of the typical 30 days for each individual report.
Over the course of 90 fast-paced minutes, Stephanie Resnik and Christopher Hanson — associates at Covington & Burling LLP, Washington, DC — will discuss which products are covered, how the program will help increase efficiency and whether it makes sense to take part in the program. You’ll learn:
Join us and discover the advantages of participating in the Voluntary Malfunction Summary Reporting Program.
Meet Your Presenters
Stephanie Resnik, Associate, Covington & Burling LLP, Washington, DC
Stephanie Resnik, an associate in Covington & Burling LLP’s Washington, DC office, advises medical device, pharmaceutical, biotechnology, food, and tobacco companies on a variety of regulatory and compliance issues, including labeling, advertising, facility registration, CGMP compliance, and reporting requirements.
Christopher Hanson, Associate, Covington & Burling LLP, Washington, DC
Christopher Hanson, an associate in Covington & Burling LLP’s Washington, DC office, advises international and domestic clients on regulatory strategies and compliance for medical devices, pharmaceuticals, biological products, radiation-emitting electronic products, and clinical laboratories.
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