NB’s New Requirements for AI-based Software
Notified Bodies have published a question catalog for medical devices with AI-based software. To meet the requirements, manufacturers should complement their processes.
How does current regulation for market access fit with artificial intelligence in medicine? Find out more by a practical example.
The technical documentation of medical devices in the EU must be revised. We tell you what to keep an eye on and how to make it a success!
Market access of medical software in the U.S. is quite different compared to Europe. Get insights about the principles.