Complaint Handling & Medical Device Reporting (MDR)

As a domestic or foreign medical device manufacturer including an importer and user facility, you are subject to regulatory requirements for complaint handling and medical device reporting (MDR) in the US.

FDA frequently cites in 483s upon establishment inspections and subsequently warning letters issued to the firms as follows.

“…Your failure to establish and maintain adequate complaint handling or medical device reporting procedures…”

This presentation is intended to help global medical device firms and stakeholders adequately implement US FDA-compliant medical device complaint handling and medical device reporting (MDR) systems. Even if it is believed that the similar or relevant procedures have been implemented in your firms, it is time to ensure all aspects of the requirements are under check to be adequate and compliant. To achieve compliance and to remain compliant with the FDA-compliant complaint handling and medical device reporting, it is imperative that the firms accurately understand, interpret, and implement the requirements for handling all complaints (electronic, written, or ORAL) and medical device reporting to be better sustainable as evident from a recent case.

In this 60-min presentation, the speaker will guide you through the details of the required elements to successfully implement the medical device complaint handling and medical device reporting systems so that you can ensure your firms adequately establish and maintain the applicable systems in a PASS-IT manner.

Areas Covered in the Session :
Applicable Laws and Regulations
Requirements for Complaint Handling
Requirements for Medical Device Reporting
Applicable Processes and Procedures
Key Elements in the Procedures: Complaint Handling and MDR
What to Do When a Complaint Is Received
What/How/When to Investigate a Complaint
Complaints Investigation and Documentation
Medical Device Reporting
How to Determine Reportable Events
Establishing Reportability Criteria
Additional Documentation Requirements for MDR
Mistakes and How to Avoid Mistakes and 483s
Relationships between Complaint Handling, MDR, and CAPA
Enforcement Case Studies
Improving Our Awareness and Continuous Improvement
Speaker’s PASS-IT suggestions and recommendations

Who Will Benefit:
Complaint Managers
Regulatory Affairs
Clinical Affairs
R&D engineers and scientists, managers, directors, VPs
Compliance and Legal Affairs
Auditors and Consultants
Senior Management
Anyone Interested in Medical Device Complaint Handling Systems

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