Post Market Surveillance (PMS) is the practice and system of monitoring the safety awareness training of a medical device after it has been released in 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.
Learning Objectives:
- 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
Why Should You 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.
Areas Covered
- FDA regulations
- EU regulations
- USP <63>
- Non-compendial based methods for Mycoplasma detection
- Compendial methods for Mycoplasma detection
Instructor Profile:
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities.
She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a CQA (Certified Quality Auditor) from the American Society for Quality.
Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.
Susanne's new book on Medical Device Quality Management Systems - Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.