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.

Risk management in medical devices is an important contribution to patient safety. But how do you perform a risk management. We tell you!

Medical imaging software is developed for clinicians. Do you know what requirements these professional users have? Here a user tells you!