Medical Device Postmarket Surveillance – PMS – How to maintain an efficient PMS system in compliance with ISO 13485, MDR
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The course provides practical guidance on how to implement the requirements on Postmarket Surveillance (PMS) in your quality management system and establish a system for proactive and reactive data collection and subsequent data/trend analysis, to identify potential and existing nonconformities. This course outlines the postmarket surveillance process; from the planning phase to implementation and analysis.
Course outline:
- How to create and update your Postmarket surveillance plan.
- Analysis and evaluation; trending.
- Important elements of your quality management system to ensure compliance to PMS regulations.
- Periodic safety update reports – new PMS reporting requirements under MDR.
- Relation between PMS, risk management and clinical evaluation.