Our solutions for medical device professionals
Patient safety, the use of AI in devices and software, and new care pathways are just some of the challenges facing medical device manufacturers. In this context, they must be flawless in terms of quality management and risk control, and be able to prove it.
This is the purpose of Regulation (EU) 2017/745, which came into force in 2021 and imposes a number of safety and performance requirements on manufacturers.
Some key figures for the sector
- 1,400 companies
- 84,000 jobs
- €32 billion in revenue
- 93% of SMEs
Your needs
Medical device professionals need best practices and to report that they are applying them. At the heart of their challenges are quality in accordance with European regulation MDR 2017/745, CE marking, cybersecurity, and the risks associated with the use of AI in devices and software.
Request CE marking
For medical device manufacturers operating in the European Union.
Apply for ISO 13485 certification
Reassure your customers and clients by displaying a recognized sign of quality.
Training in medical devices
AFNOR Compétences offers four training programs.
Subscribe to the medical device standards package
Regulatory monitoring for very small businesses.
Medical devices: they apply best practices
Manufacturers of devices, control software, etc. All need best practices and come knocking on AFNOR's door.
