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IN-HOUSE & INTER-COMPANY TRAINING

Our training courses

We offer in-person and remote training to equip your teams with usability engineering (IEC 62366) skills for medical devices.

Training

Usability Engineering (IEC 62366) Training for CE marking of MD

EN 62366-1TR 62366-2ISO 60601-1-6

The usability engineering process aims to identify and reduce use-related risks: it is a crucial step to ensure the safety of your medical device (MD) and obtain its CE marking under the MDR and IVDR.

Target audience

MD manufacturers | Project owners | Project managers | Regulatory affairs officers | Quality managers | R&D engineers | ... and anyone involved in MD development

Objectives

  • →Master the vocabulary and concepts of EN 62366
  • →Understand the requirements of EN 62366-1, TR 62366-2 & ISO 60601-6
  • →Understand the steps to implement the usability engineering process

Modalities

  • •In-house or inter-company training
  • •1 or 2 days of in-person or remote training

Why take our IEC 62366 training?

  • Training delivered by a domain expert who has supported many manufacturers on MDs of all classes and types (implantable, IVD, software, radiology, etc.)
  • Interactive approach with case studies, discussions and exercises tailored to your products.
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Usability Engineering (IEC 62366) Training for CE marking of MD
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Need a tailored training programme?

We adapt our training to your products, your schedule and the specific needs of your teams.