Best Practices for Implementing an Adverse Event Reporting System for Medical Devices Including IVDs

This training on Medical Device Reporting (MDR) requirements will provide attendees the best practices for implementing an adverse event reporting system for medical devices including in vitro diagnostic devices (IVDs).

Why Should You Attend:

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 these incidents. MDR is the mechanism for the FDA to receive reports of 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 accurately interpret and understand the applicable medical device reporting regulations to adequately implement an adverse event reporting system for medical devices including IVDs.

This 60-min webinar will provide a great opportunity to help establish and maintain adequate procedures for medical device reporting in a way that one would differently plan, develop and execute the relevant procedures in an efficient and effective manner.

During this webinar, the speaker will share his practical, actionable and sustainable perspectives to help attendees increase awareness and familiarity of the regulatory requirements.

Areas Covered in the Webinar:

• Applicable statutes and regulations
• Definitions
• Regulatory requirements for Medical Device Reporting
• How to report an adverse event
• Reporting requirements for the user facilities, manufacturers, and importers
• Required elements to be contained in your standard operating procedures
• How to implement an adverse event reporting system
• Enforcements: Case Studies
• Good Practices
• Conclusion

Who will Benefit:

• CEOs
• VPs
• Regulatory affairs (associates, specialists, managers, directors or VPs)
• Quality professionals (associates, specialists, managers, directors or VPs)
• R&D (engineers, scientists, managers, directors or VPs)
• Complaint and risk management personnel
• Consultants
• Contractors/subcontractors
• Clinical affairs (associates, specialists, managers, directors or VPs)
• Other interested parties

Instructor Profile:

Dr. David Lim, Ph.D., RAC, ASQ-CQA is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.com). Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, he developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, he developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. He 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.