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Post-market Surveillance (PMS) is one of the most complex processes in medical device quality management systems due to its interface to many other processes, such as
- Complaint Handling
- Vigilance/Medical Device Reporting
- Risk Management
- Clinical Evaluation/Post-market Clinical Follow-up
A large amount of data has to be collected from different sources, evaluated, analyzed and summarized. This includes internal data from the company's own products, but also external data for similar devices such as publications from literature reviews and adverse event/recall reports from databases of national authorities. Results of the evaluation must be used as input in other processes, for which a clear traceability must be demonstrated. Furthermore, the MDR mentions specific documents such as PMS Plan, PMS Report and PSUR, that must be created on a regular basis for each device/device group.
In summary: Post-market surveillance activities are costly and require many resources.
This TechTalk addresses the following questions:
- How can required activities be performed in an efficient way?
- What is the potential of software solutions for PMS processes?
- What can be automated, what are the current limitations?
- What is required to achieve digital continuity across all PMS activities?