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Updates on Medical Device Post-Market Reporting Regulations
Updates on Medical Device Post-Market Reporting Regulations

Our Price: $395.00

Product Code: WB-7090

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Includes 1 hour and 20 minute Windows Media Video File and PowerPoint presentations for immediate download.

Medical device reporting is one of the most common post-market surveillance activities required of all medical device manufacturers in accordance with the Medical Device Reporting (MDR) regulation (21CFR 803). The FDA requires device companies to account for certain instances of adverse events and product problems in order to ensure safety issues can be identified and addressed quickly. The FDA recently revised MDR policies and published a final rule stating that manufacturers must submit MDRs in an electronic format, which is aimed at improving the FDA’s process for collecting, reviewing, and archiving adverse event information. It is essential for device manufacturers to fully understand and prepare for these changes as the rule will go into effect on August 14, 2015.
  • MDR overview focusing on current trends and interpretations
  • Summary of mandatory reporting requirements for manufacturers
  • Navigating through MDR grey areas
    • Product versus satisfaction complaint
    • Device repair versus complaint
  • Additional noteworthy guidance in final rule

Jeffrey K. Shapiro

Hyman, Phelps & McNamara, P.C.

Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
  • Regulatory Affairs
  • Medical Device Reporting
  • Post-Market Surveillance
  • Quality Systems

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