Post Market Surveillance (PMS) is the practice and system of monitoring the safety awareness training of a medical device after it has been released on the market.
It relies on several foundations including unique device identifiers (UDI), electronic health records and medical device reporting, device registries, and advance methods for evidence generation, data analysis and vigilance awareness training. It is a system that continues to develop and improve.
Why You Should Attend:
Post Market Surveillance is an essential part of the FDA’s mandate to protect the public health. This Post Market Surveillance and Vigilance Webinar will establish why it is something that every medical device company needs to understand to ensure product safety and effectiveness and customer satisfaction.
This webinar will discuss the essentials of Post Market Surveillance, how you can develop your capabilities and how PMS can provide you with important information to improve your device, better service your customers, and reduce the risk of adverse events.
- Overview and Definitions
- FDA Expectations, Regulations
- Investigating a complaint or MDR
- FAERS – FDA Adverse Event Reporting System
- Common Mistakes and how to avoid them
- Best Practices
- Lessons Learned and Enforcement Case Studies
- Medical Device Reporting
- Preparing for an FDA or NB Inspection
- Regulatory Affairs Departments
- Quality Departments
- Compliance Departments
- Engineering Departments
- Clinical Affairs Professionals
- Complaint Specialists and Managers
- Individuals participating in Failure Investigations
- Individuals analyzing Returned Products/Complaint Analysis
- Complaint Handling Unit Personnel