Implementing Medical Device Global Adverse Event Reporting Systems

The purpose of this session is to get you acquainted with adverse event reporting requirements and systems in EU, Canada and US. The obligation of Medical Device Manufacturers doesn’t end after obtaining a clearance, approval, registration, listings or certificates. They are required to report adverse events to the health authorities (e.g., Competent Authorities, Health Canada and US FDA) wherever applicable. To achieve compliance and remain compliant with adverse event reporting requirements, it is imperative that medical device manufacturers understand what requirements apply and how to meet those prescribed requirements.

In this conference, our presenter will walk you through the applicable adverse event reporting requirements and help you understand them clearly as well as explain how to remain in conformity with the requirements in EU, Canada and US. Going further with the session, Dr. Lim will help you change your way of planning, developing, implementing and following your relevant and applicable processes so that you do it efficiently and effectively. In this conference, you will be able to become familiar with Global Adverse Event Reporting (AER) systems and also ensure if your current AER system are compliant enough.

Areas Covered in the Session :
Applicable and relevant laws and regulations in EU, Canada and US
Medical device adverse event reporting requirements in EU, Canada and US
Medical device vigilance system during the post-production phase in EU
Mandatory medical device problem reporting requirements in Canada
Mandatory medical device reporting requirements in US
Review of actual reporting forms in EU, Canada and US
Applicable and relevant guidance documents
Common mistakes and how to prevent them
Best practices
PASS-IT solutions

Who Will Benefit:
Compliance Officers
Regulatory Affairs
Clinical Affairs
Quality Assurance
Research & Development
Anyone Interested in the FDA inspection Process

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