ISO 14971 was created to address the need for a standard Risk Management framework, designed specifically to meet the requirements of the medical device community. Beyond product safety, ISO 14971 provides a broader outline for Risk Management, providing guidance on the processes for managing risks to the patient as well as the operator, other persons, other equipment and the environment. This requires manufacturers to test the medical device during design and development as well as prepare for how quality will be upheld when put to use under various circumstances.
This is a password protected area. If you already have an existing account please login now.
If you would like to sign-up for an account, please click the register now button.
Please note that Dyadem only accepts corporate email addresses.
Register Now