We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Store » Device Products » Medical Device Voluntary Malfunction Disclosure Regulation - Webinar Recording/Transcript

Other Options

Audio Recording/Transcript - Dec. 18, 2018

$287.00

Audio Recording/Transcript - Dec. 18, 2018

$258.00

Audio Recording/Transcript - Dec. 18, 2018

$244.00

Audio Recording/Transcript - Dec. 18, 2018

$230.00

Audio Recording/Transcript - Dec. 18, 2018

$215.00

Medical Device Voluntary Malfunction Disclosure Regulation - Webinar Recording/Transcript

$287.00
Device Products

Product Details

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:

  • 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 and discover the advantages of participating in the Voluntary Malfunction Summary Reporting Program.

  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing