Post-Market Clinical Follow-Up (PMCF) is where many teams discover whether their post-market evidence plan is proportionate and workable. Once a device is on the market, the questions do not stop. In some cases, they become more specific: continued safety, real-world performance, residual risks, long-term use, or evidence gaps that were accepted on the basis that post-market follow-up would close them.
Qmed supports PMCF studies as an EU medical device CRO and consultancy. We help manufacturers shape the right PMCF approach, plan and run the work operationally, and keep the outputs connected to CER, PMS, and PSUR rather than treating the study as a stand-alone exercise.
What this service covers
Support can include PMCF planning inputs, study objectives, protocol and document development, country and site strategy, submission support where required, monitoring, data handling, safety oversight, analysis coordination, reporting, and close-out.
Depending on the device and the evidence question, PMCF can take different forms. The key is not to force one format onto every problem, but to choose a study model that is proportionate, useful, and capable of producing evidence that can actually be used downstream.
When PMCF becomes the right next step
Teams often know they need more post-market evidence, but they are not yet sure whether that should be a formal PMCF study, a broader post-market study, or a wider PMS activity. That decision matters, because it affects cost, complexity, timelines, and how the resulting evidence can be used.
Qmed helps make that call and then supports execution in a controlled way. For clients that need it, we can also structure the work fractionally, so support is focused on the parts of the PMCF programme that matter most at that stage.
Talk to Qmed
Tell us what post-market evidence questions you need to answer and whether you need support with planning, execution, or both.