Compliance
Post-Market Surveillance
TL;DR
Post-Market Surveillance — the lifelong, proactive, documented programme of collecting and acting on real-world performance and safety data after a device is on the market.
Post-Market Surveillance — the lifelong, proactive, documented programme of collecting and acting on real-world performance and safety data after a device is on the market. EU MDR Articles 83-86 made the PMS plan, PMS report and PSUR mandatory deliverables for every device on the EU market; FDA QSR/QMSR, ISO 13485 §8.2 and MDSAP all impose substantively equivalent expectations. The subsystem that closes the loop from field reality back to the risk file, technical documentation, IFU and design.
Industries that live with this
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