Date: 14th of November 2019
Location: The Netherlands, Amsterdam area
Costs: 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
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.
Note: this training can also be provided in-house for
other organizations in the supply chain involved in one or more
stages of the life-cycle of a medical device, including design and development,
production, storage and distribution, installation, servicing or provision of
associated activities. The contents will be adapted to the specific role(s) of
Why should you
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 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
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.
- Learn to
look at PMS in a practical way, integrating it into daily operations
the difference between active and reactive PMS/PMCF, and when to use what
the full impact of the new EU-MDR on PMS and PMCF principals in continued
how to apply PSUR and SSCP
how to build and use checklists, tools, and templates
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
Questions & Answers
Evaluation of the Course and Closing
Who should attend this course?
RA manager, RA director, QA manager, QA director, Clinical Director,
Marketing Manager, Sales Manager, international registration department.