Date: 22 August 2017
Time: 5:30 – 8:30 PM
Location: Crowne Plaza Aire – Mall of America (Minneapolis area)
Event Title: Clinical Evaluation in the EU for medical devices – Changing Expectations
What are the top 3-5 takeaways/lessons that will be learned by attending?
1 ... that being able to demonstrate “equivalence” is now much more difficult (e.g. must use a single device for this, rather than many; must have full access to the technical documentation so, in essence, must “own” the technical documentation for the device to be claimed as “equivalent”)
2 … high-level strategy for bringing devices which use equivalence now into compliance with the MDR (which allows “no equivalence”, unless you have full access to the technical file).
3 ... when clinical investigations are now expected (more frequently than before)
4 ... that CERs should be generated at several points in the product lifecycle (development, initial CE marking, post-market) and the focus at each stage
5 … that clinical evaluators must be more highly qualified now and the specific requirements
6 … the expectation for how to develop and execute suitable clinical literature searches
The RAPS Twin Cities Chapter is a community consisting of 14,000+ regulatory proffessionals worldwide. The RAPS Twin Cities Chapter conducts a number of professional development and networking activities throughout the year to help members connect, build relationships and increase knowledge, competence and performance.
With offices in the USA, Europe, and China, Qserve is an interesting partner for international medical device manufacturers because with our global team of experts we can offer all expertise, experience and language skills needed to give international support on a local level.
For more information and subscription about this event, please check the website of RAPS