The U.S. President has signed an Executive Order to strengthen the cybersecurity of government entities. The implications extend beyond government entities.
To prove the safety and performance of AI-based software as a medical device, there are special documentation requirements due to data management and model development.
Cyber security threats affect medical device safety and patient protection. Learn here how to perform best regarding risk management.
Safety risks have always been considered in risk management according to ISO 14971. But what is about upcoming security risks?