EU Medical Devices Regulation and In Vitro Diagnostics Regulation are bringing increased post-market surveillance (PMS) requirements for all MedTech firms.
Multiple factors, including the rapid growth in device interoperability, the rise in Software as a Medical Device (SaMD), and increasingly frequent cybersecurity breaches, have been responsible, in part, for the continued rise in recalls, particularly software-related recalls. In this Executive Summary of a recent webinar learn about:
- Challenges with post-market surveillance
- Understanding real world evidence
- The future post-market surveillance safety landscape
- How to set up a better post-market surveillance approach