ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services. ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medica... https://3mconsulting.co.in/iso-certification/iso-13485-2016-certification-consultants-medical-devices-india/