The new 2017/745/EU Medical Device Regulations (MDR-2020) require increased emphasis on Post- Market Clinical Follow-Up (PMCF) as a part of clinical evaluation to demonstrate conformity to safety and performance of devices. Many device manufacturers are unaccustomed to conducting post- marketing clinical studies and tend to regard study activity as both costly and time-intensive. Proper design, planning and execution of PMCF studies are essential to ensure return on investments. This webinar will focus on pitfalls and challenges in planning, conducting, and managing PMCF studies. It will discuss approaches that can be utilized to optimize resources and mitigate risk.
The webinar will cover the following topics:
- Protocol development to support business needs
- Study conduct in compliance with ISO:14155
- Collecting safety data
- Centralized monitoring
- Tools consideration