Successfully Conduct PMCF with These Resources

After a device is placed on the market, manufacturers will have to continuously, and proactively, gather data on the device’s safety and clinical performance, which is laid out in a PMCF plan.

A brief, in-depth guide on the process of sample size calculation for medical device studies.

A dive into the MDR requirements for PMCF for Medical Devices, its advantages, and its pitfalls. 

The MDR is very clear on what a PMCF plan should include, but the choice of strategy can greatly vary from one device to another.

If you are looking for guidance on your choice of strategy for your medical device PMCF plan, this webinar is for you.

Insights to ensure that your methods and data pass Notified Body scrutiny.

PMCF plays a major role in PMS under the MDR. With the right implementation of PMCF safer medical devices will reach healthcare. But that begins with a clear understanding and guidance on PMCF.