Medical Devices - Developing Effective Post Market Surveillance and Complaint Handling Systems

As users and regulatory agencies are becoming less ‘tolerant' of medical device failure, regulatory agencies are placing greater emphasis on post market surveillance as a way to improve risk management and protect public health. This course will review the regulatory expectations for post market surveillance and outline how to apply the requirements to medical devices. Topics include: complaint handling & vigilance systems, Medical Device Reports (MDR), implementation challenges, medical device tracking, impact of post approval studies, compliance requirements & meeting them, and complaint systems inspections.

Throughout the course, examples and case studies will help participants apply the concepts being covered.

Jonathan Lee has more than 25 years of broad-based medical device experience with extensive Quality System experience encompassing ISO, MDD & GMP standards and regulations, through consulting and senior management positions in QA/RA, R&D, Project Management, Product Management, and Product Introduction disciplines, in both the United States and Australia

A multiple patent holder, Mr. Lee’s prior roles include VP R&D at Cardiac Control Systems, Vice President Quality, Regulatory & Clinical affairs at Medtronic. In addition, his consulting roles supporting implantable bio stimulation telemetry systems, implantable heart sub-system, catheter defibrillation system, surgical tool, vertebral stiffness measuring system, respiratory interfaces, cardiac catheter development, medical device process V&V, quality system development & implementation, and product approvals, have provided for an extensive accumulated experience.

Today, as Principal Consultant and Managing Member of “MedDev Consulting Solutions International” he provides strategic direction and tactical solutions for unique medical device challenges. Including areas such as integration of quality systems with compliance, product performance and elevated stakeholder expectations.

Mr. Lee holds an Electrical Engineering (Biomedical) BE degree from the University of NSW in Australia with post graduate work in Computer Studies at the same University. He has participated in compliance symposia at Harvard University and served as an instructor on quality systems at University of Southern California School of Pharmacy Master’s Degree Program.