Post market Surveillance (PMS) and its subset of Post Market Clinical Follouw-up (PMCF) increasingly become part of the regulatory lifecycle thinking of modern medical device regulations. Moving away from the historic one-time review on compliance prior to market access, PMS needs to be set up as a system that provides continuous feedback about a device on the market in order to maintain a high standard of product quality.
Post-market surveillance requirements are in direct relation to risks associated with the device based on its intended use, such as the product or technology begin new to the manufacturer and the extent of the available scientific knowledge and market experience with similar products. Actual product-specific plans for gathering post-production data about your product or product-family need to be set up for the lifetime of the device.
Regulatory bodies across the globe are imposing increasingly demanding and prescriptive requirements for post-market surveillance. In particular, regulatory bodies are establishing specific requirements for more proactive post market surveillance mechanisms, rather than relying simply on reactive systems, such as complaints monitoring.
Why attend this course?
This training focusses on practical guidance to deliver the life-cycle concepts in the EU-MDR on PMS and PMCF. It clarifies why PMS plans and PMCF plans are part of annex ll technical documentation that needs to be ready before the market introduction of new products. It will clarify the current interpretation on the differences between active and reactive activities of PMS, and it will provide insight into how to implement the risk-based approach
The training will give guidance on how to determine what PMCF data is required and how this should be collected when needed. Furthermore, the requirements for Periodic Safety Update Reports and for Summary of Safety and Clinical Performance will be highlighted. The day will be filled with discussions and case studies
Who should attend this course?
RA manager, RA director, QA manager, QA director, Clinical director, Marketing manager, Sales manager, International registration department
We offer open enrolment, on-location, train-the-trainer formats.
Please contact us to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time.
Costs: € 875.- p/p for a one-day training