Leveraging Post-Market Clinical Follow-Up (PMCF) Data for Monitoring Safety and Performance of your Medical Device
This workshop educates participants to develop and execute a PMCF plan as part of their post-market surveillance (PMS) obligations to mitigate risks of non-compliance and potential regulatory sanctions.
Workshop Outline:
1. Overview of PMCF requirements for regulatory compliance in various countries/regions
2. Understanding the role of PMCF in collecting clinical data to assess safety, performance, and benefit-risk of medical devices
3. Examination of different PMCF data collection methods and a discussion on the strengths and limitations of each approach
4. Discussion on the strengths and limitations of each approach and considerations for selecting the most appropriate method.
5. Strategies for mitigating common challenges in PMCF data collection, such as patient follow-up, data completeness, and bias.
6. Analyzing and interpreting PMCF data and utilizing the data for
7. Case studies illustrating how PMCF data can inform risk assessment, labelling revisions, design modifications, and overall PMS strategies.
8. Best practices for PMCF planning based on learnings from notified body reviews of PMCF Plans.
9. Interactive exercises – choosing appropriate PMCF strategy for different device types, extracting significant information from simulated PMCF datasets and deciding the impact on other parts of the technical documentation.