Compliance with IEC 80001 – Best Practices for Medical Device Companies

• By: Staff Editor
• Date: October 06, 2011

IEC 80001 is an international standard for managing risks in IT networks using medical devices. Its aim is address issues of safety, effectiveness, data, and system security in the network. The standard defines the process and also defines responsibilities for each of the stakeholders involved. It recognizes that risk management should be applied throughout the lifecycle of the networks. 

This article discusses the best practices for medical device manufacturers to comply with this standard.