The risks of a medical device must be acceptable in comparison to its benefits. Manufacturers must therefore carry out a risk management process. Read how this works in this article.
Risk management in medical devices is an important contribution to patient safety. But how do you perform a risk management. We tell you!
Safety risks have always been considered in risk management according to ISO 14971. But what is about upcoming security risks?
Then subscribe to our newsletter and get practical insights about all relevant regulatory aspects.