January 17, 2019 - January 17, 2019
Date: 17 January 2019
Duration: 1 Day
Location: Amsterdam, The Nederlands
Language: Presentations will be in English
Cost: Regular € 875.-
Post Market Surveillance (PMS) and its subset of Post Market Clinical Follow-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 being 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.
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 II 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 you guidance on how to determine what post-market clinical follow-up (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.
- PMS and PMCF in global setting
- PMS and PMCF in EU - Medical Device Regulation
- Regulatory Life cycle concepts, embedding PMS and PMCF in QMS
- PSUR & SSCP requirements
- Case studies
- Questions & Answers
- Evaluation of the Course and Closing
- Learn to look at PMS in a practical way, integrating it into daily operations
- Learn the difference between active and reactive PMS/PMCF, and when to use what
- Understand the full impact of the new EU-MDR on PMS and PMCF principals in continued market approval
- Know how to apply PSUR and SSCP
- Understand how to build and use checklists, tools, and templates
Who should attend:
RA manager, RA director, QA manager, QA director, Clinical Director, Marketing Manager, Sales Manager, international registration department