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.

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

3 day public classroom

Medical device qualification pathways

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Recognizing competence with BSI

Go beyond training with a qualification pathway, increasing your skills and adding more value to your organization. You will demonstrate competence through the assessment of learning and validation of relevant, practical application with evidence-based certification.

Start your qualifications journey >

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?

Speak to our training advisors on +1 800 862 6752

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