Q: What is ISO 13485?

A: ISO 13485 is a standard that provides specific requirements for the application of ISO 9000 to the medical devices industry for regulatory purposes.

The standard helps to ensure the consistent application of quality requirements in the industry. In Canada, ISO 13485 is the basis for the Canadian Medical Devices Conformity Assessment System (CMDCAS).  Abroad, it is being applied as part of the regulatory regime for medical devices in a number of countries.