Our artificial intelligence solutions for medical device professionals

The risks associated with artificial intelligence are a critical issue for the medical device industry, as more and more medical devices incorporate AI. Check out our toolkit to effectively manage these risks in your company or laboratory.

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Your needs

Do you work in the medical device (MD) sector in roles that involve risks related to artificial intelligence? We offer you access to our standards committees, training programs, certifications, and, of course, CE marking.

Apply for ISO 42001 certification

Reassure your customers and clients by displaying a recognizable logo.

Apply for ISO 42001 certification

Certify your skills in DM

Establish your credibility as an expert in regulatory compliance specific to medical devices.

Certify your skills in DM

Request CE marking

For manufacturers of medical devices that incorporate AI.

Request CE marking

Training on AI Risks for Medical Devices

A two-day training course with AFNOR Compétences.

Training on AI Risks for Medical Devices

AFNOR helps you define your needs

Thomas Lommatzsch
Virginie DesbordesArtificial Intelligence ExpertSee his Linkedin profile
Contact our expert

Why manage AI-related risks?

More and more medical devices are incorporating technical solutions based on artificial intelligence. This is particularly true of devices used for medical diagnosis, especially medical imaging equipment. Indeed, artificial intelligence can help analyze and interpret results, having first been trained to read a vast number of medical reports.
This is known as predictive analysis. However, human oversight remains essential to evaluate the responses provided, given the potential for error. The concept of high-risk AI is central to the 2024 European regulation on AI, known as the AI Act.

Source: Statista, INSEE, Galeon, LEEM

78 billion eurosThe Global E-Health Market in 2025

10 %French companies will be using at least one AI-based tool by 2024

34 %French people have used generative AI in relation to their health

191French AI startups in healthcare in 2020

What is the ISO 42001 standard, “Artificial Intelligence Management System”?

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