Notified Bodies have published a question catalog for medical devices with AI-based software. To meet the requirements, manufacturers should complement their processes.

Segregation is an important strategy in software development for reducing complexity. Find out how to apply segregation to your software.

Risk classification for medical apps has changed significantly with the European Medical Device Regulation. We give you an example!

You must understand the importance of protecting your trade secrets or the development of your medical software was useless!

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!

Healthcare cybersecurity in the U.S. encounters basically the same threats as everywhere but unique challenges apply as well.

Market access of medical software in the U.S. is quite different compared to Europe. Get insights about the principles.