IAF/ILAC video on Accreditation, Adding Value to Supply Chains: The Medical Devices Supply Chain
How does accreditation help ensure the safety of medical devices? ISO 13485 is the world’s most recognised medical device standard and ensures excellence in the provision of medical devices. Its primary objective is to facilitate harmonised medical device regulatory requirements by providing an effective solution to meet the comprehensive requirements for a quality management system. ISO 13485 provides a practical foundation for manufacturers to address regulations and responsibilities, as well as demonstrating a commitment to the safety and quality of medical devices. Accredited certification is used to assess conformity of medical devices against this standard.