Medical Device Reporting – How to establish and maintain adequate procedures

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This webinar is intended to help you avoid FDA 483s and warning letters for failure to establish and maintain adequate procedures for medical device reporting.

Device manufacturers are required to establish and maintain medical device reporting procedures pursuant to the FDA regulations.

In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. MDR is the mechanism for the FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. To achieve compliance and to remain compliant, it is critical to understand how to define, document and implement the MDR procedure to survive FDA inspections – avoiding FDA 483s and warning letters.

This webinar is aimed at helping device industry understand how to establish and maintain adequate procedures for MDR and further to provide practical and actionable perspectives by increasing awareness and familiarity of the applicable requirements.

In this webinar, you will learn what is required to achieve compliance and stay compliant with MDR regulations.

Areas to be Covered:

Applicable Statues and Regulations
MDR Regulatory Requirements
MDR Standard Operating Procedures (SOPs): Required Elements
MDR Criteria
Determining and Reporting MDR Events
Reporting Requirements for the User Facilities, Manufacturers, and Importers
Integrating Unique Device Identification (UDI)
Enforcements: Case Studies
Common Mistakes and Consequences
Best Practices
Speaker’s PASS-IT Solutions

Who will Benefit:

A must webinar for all personnel in:
Clinical Affairs
Regulatory Affairs
Research & Development
Complaint and Risk Management
Senior Management
Other interested parties

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor ( As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance