Medical Device Voluntary Malfunction
Disclosure Regulation
Are You Up to Date on the Latest Developments?

Tuesday, Dec. 18, 2018 · 11:00 a.m. - 12:30 p.m. EST

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:

  • Background of the Voluntary Malfunction Summary Reporting Program including:
    • Origins of the program
    • FDA’s intentions in establishing the program
    • Types of manufacturers, devices, and events eligible to participate in the program
  • How the Voluntary Malfunction Summary Reporting Program differs from individual malfunction reporting
  • Benefits to device manufacturers including the efficiency advantages offered by the program
  • Conditions under which the program is not available to manufacturers
  • And much more…

Join us on December 18 and discover the advantages of participating in the Voluntary Malfunction Summary Reporting Program. Register today.

Who Will Benefit

  • Quality Managers
  • Quality Engineers
  • Production Managers
  • Production Supervisors
  • Manufacturing Engineers
  • Production Engineers
  • Design Engineers
  • Process Owners

Webinar plus Audio Recording/Transcript
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Webinar only
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$287

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24/7 Encore plus Audio Recording/Transcript
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24/7 Encore Presentation
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$287

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Audio Recording/Transcript
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$287

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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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