CE marking training courses

CE marking training courses

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CE marking is the medical device manufacturer’s claim that a product meets the General Safety and Performance Requirements (GSPR) of all relevant European Medical Device Regulations and is a legal requirement to place a device on the market in the European Union.
Given the stringent requirements on patient safety and device performance, accessing the European market brings challenges that can delay your product launch.

Discover our CE marking dedicated training portfolio, developed to increase your understanding in navigating the CE Certification process and to increase your readiness for market.

Course list

Implementation of the in vitro diagnostic device regulation for CE marking training course >

Designed to guide you through IVDR requirements implementation to obtain and maintain CE mark for in vitro diagnostic medical devices. Learn more about IVD classification rules and conformity assessment routes. Increase your knowledge on General Safety and Performance Requirements in product development, performance evaluation and clinical evidence.

3 day public classroom

Medical device qualification pathways


Why BSI?

  • Trained 70% of the top 100 medical device companies
  • Medical Device Qualifications
  • Internal expertise
  • Global scale
  • A full scope Notified Body

Not sure what course is right for you?

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