Skip to content Our resources of legal requirements for medical software help you to find all important laws, guidelines, and standards. The MDR caused uncertainty concerning software classification. We give you an exclusive insight into the upcoming EU guideline! It's hard to achieve MDR compliance when developing medical apps. Learn in this presentation how to overcome this hurdle. Risk classification for medical apps has changed significantly with the European Medical Device Regulation. We give you an example! 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.