Medical Device Interface Standards?

1. What is the ISO standard for medical devices?
2. What is medical device interfaces?
3. Is ISO 13485 mandatory?

What is the ISO standard for medical devices?

ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

What is medical device interfaces?

User interface includes all the physical elements of a medical device that enable interaction between the user such as doctors, nurses and patients, as well as the device itself.

Is ISO 13485 mandatory?

The short answer is no, ISO 13485 is not mandatory. You can create a QMS that suits your needs for your organization, so long as the processes of the QMS meet the legal and regulatory requirements for medical devices where you intend to manufacture and sell them.