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Recorded Webinar

FDA Medical Device Regulation : Overview of Complaint Handling and Medical Device Reports (MDR)

timelapse 60 mins with 10-15 mins of Q and A

Note:

This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times

Speaker/Presenter

Short Abstract

Complaint handling and reporting of adverse events related to the use of medical devices is a regulatory requirement in most regulated medical device markets. This course is an overview of FDA’s requirements for complaint handling and Medical Device Reporting (MDR). It includes definitions, regulatory requirements, how to respond to a complaint that reports a possible MDR, and how to file an MDR with the FDA.

The presentation will cover the following areas:

  • What is a complaint?
  • What are FDA’S requirements for complaints?
  • What is an MDR?
  • What are the FDA’s requirements for Medical Device Reports?
  • How to file an MDR


Apply for this webinar

Who should attend

Anyone involved in complaints and complaint handling, especially: Customer service, technical service, sales & marketing, RA/QA, and anyone seeking an overview of FDA’s complaint and MDR requirements.

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