More and more medical devices are using artificial intelligence to diagnose patients more precisely and treat them more effectively.

Although many products have already been approved (e.g. by the FDA), many regulatory issues are still unanswered.

This article describes what manufacturers should pay attention to if their products are based on artificial intelligence processes.

Contents 1. AI: What it is » 2. Applications of AI in medicine» 3. Regulatory glasses » 4. Free guide to AI» 5. Support » 6. AI: a conclusion»

Please also note the guidelines for the use of artificial intelligence (AI) in medical devices , which the Johner Institute developed with AI experts and notified bodies. Find out more here… .

Artificial intelligence video series

A short (four-part) series of video training is available here free of charge. The audit guarantee offers even more extensive support (25+ video training courses on AI, templates).

  1. Part: Introduction, overview of applications and procedures
  2. Part: Quality measures for evaluation
  3. Part: Regulatory Requirements
  4. Part: Recording the webinar
Fig. 1: Free series of four videos on artificial intelligence in medical devices. A comprehensive series (25+ videos) can be found in the audit guarantee . 1. Artificial intelligence: what is it?

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