Post-Market Surveillance (PMS) under MDR and IVDR is not one document or one review meeting. It is the ongoing system for collecting, reviewing, analysing, and acting on information about the device once it is on the market.
Many organisations have parts of that system in place but not a controlled end-to-end model. Qmed helps manufacturers build, improve, and operationalise PMS so it fits the device portfolio, the organisation, and the regulatory obligations that sit around it.
What this service covers
Support can include PMS planning, procedure development, role and responsibility mapping, data-source design, complaint-handling interfaces, service and commercial feedback loops, trend review, PMCF integration, vigilance connections, CAPA triggers, reporting cadence, and portfolio-level governance.
That support can be delivered as an initial build, a gap assessment and remediation project, or ongoing fractional support where the system exists but needs stronger oversight and execution discipline.
What a working PMS system should include
A working PMS system should make it clear what information is being collected, who reviews it, how decisions are made, when escalation is required, and how the outputs connect to CER, PMCF, vigilance, and PSUR. It should be proportionate to the device and the business, not overbuilt for its own sake.
This is often where teams realise the real issue is not a missing template but a missing operating model. Qmed helps close both gaps: the documented system and the way the system actually functions in practice.
Talk to Qmed
Tell us how your PMS system is set up today, where the pressure points are, and whether you need design support, remediation, or ongoing reinforcement.