Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications
Organizer: The Center for Professional Innovation & Education
Start: Thursday, 12 October 2017 @ 09:00
End: Friday, 13 October 2017 @ 17:00
Timezone: Central European Time Zone
Sponsors: The Center for Professional Innovation & Education
Venue: The Berlin Hilton
Country: GermanyTarget audience:
- Medical Device
Things are changing for Medical Devices and IVDs in the European Union (EU): new fundamental standards, new EU device regulations and BREXIT. What is now needed to enter or, more importantly, to maintain presence in this attractive marketplace for medical devices? Satisfying requirements harmonized across the 28 member states should be a straightforward process to get products approved for distribution in each country - but is it?
This course identifies and explains the requirements – old and new – for medical devices, the steps to obtain entry into the marketplace (including setting up on-going procedures and relationships), the increasing importance of Clinical Evaluation and Post Market surveillance, Notified Bodies and Competent Authorities. The course also shares some lessons learned from the Course Director, who has over 25 years of experience with CE marking medical devices for distribution in the EU.
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- First come first served
Keywords: EU Directives, Guidance, CE Marking, ISO Standard