Implementing and Maintaining PMS and Performance Evaluation under the IVDR
Thursday September 29th | 10 am Central US Time
James Shearn, Regulatory Affairs Consultant – Medical Devices and IVDs
The presentation will include:
- The role of PMS within the Quality Management System and its linkages with other processes including vigilance and management review
- How the PMS cycle gathers data and drives the creation of IVDR deliverables including the Periodic Safety Update Report (PSUR) and Summary of Safety and Performance (SSP)
- How the PMS cycle interlinks with clinical evidence to drive updates to the Performance Evaluation Report
Regulatory Affairs Consultant – Medical Devices and IVDs
James Shearn has a degree in Medical Electronics and has worked in the Medical Devices and In Vitro Diagnostic Devices (IVD) sector for 27 years. His early career was in medical device research and development, before shifting focus to Regulatory Affairs.
Throughout his career James has held roles with several large manufacturers, working in the fields of drug infusion systems, cardiology and diabetes management. His most recent industry role was as Vice President Regulatory Affairs & Quality Assurance at Oncimmune, an immunodiagnostics company with a focus on the early detection of cancer and autoantibody profiling of autoimmune and infectious diseases. James has also worked as an independent regulatory consultant, predominantly with Small and Medium Sized Enterprises (SMEs) and has recently returned to the consulting space.
For More Information, Contact:
Division Director, Life Science Programs