Our training courses

Dedicated to medical devices

Expert, Qualiopi-certified training courses on medical devices

Dedicated to CE marking, quality management systems, approval, etc., our medical device training courses are governed by a Qualiopi-certified process since January 2022. Tailor-made, they meet the normative and regulatory requirements for medical devices (QMS, ISO 13485, CE marking / FDA...).

Our experts provide you and your teams with all the knowledge and advice you need on the subject of medical devices. To help you understand and implement your technical files, or to train your new employees, they use their own experience, supplemented by active monitoring, to share their know-how. Depending on your needs, our trainers can help you deploy a quality management system in your company. They can also teach you how to draw up a technical file for medical devices, or train you to obtain CE marking.

Our training courses

Find out more about our catalog of training courses for medical device manufacturers and their subcontractors:

CE marking training courses for medical devices

Our CE marking courses for medical devices give you the knowledge you need to apply medical device procedures by yourself. Depending on your needs, we offer other complementary training topics:

  • Drawing up a CE marking file
  • Design and development of a medical device according to MDR 2017-745 and ISO 13485_2016
  • Setting up your QMS - ISO 13485 as a manufacturer
  • Setting up a QMS - ISO 13485 for subcontractors
  • Risk analysis
  • Suitability for use
  • Classification
  • Biological evaluation
  • Purchasing, supplier and supplier contract management
  • Change management
  • Document management
  • Environmental and manufacturing management
  • GSPR - General Safety and Performance Requirements
  • MDR 2017-745
  • Rated performance
  • Bibliographic research
  • Process validation
  • Software validation
  • Conformity assessment track
  • Other training courses are also possible!

Disability policy

We do everything possible to make our training courses accessible: please let us know before you register, so that we can establish the necessary adaptations. Agefiph is one of our resource partners for optimal training for people with disabilities.

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Excellent performance indicators

All our training courses are followed by a questionnaire to measure the satisfaction of each participant, as well as that of decision-makers and funders.

98%
satisfaction rate
100%
of
recommendation rates
14
years
of expertise

Master medical device requirements with our training courses

We're at your side, so let's talk about your needs!

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