ISO 13485 CMDCAS
Medical Devices – Quality Management CMDCAS
The ISO 13485 is an internationally recognized standard and is aimed at manufacturers of medical devices and providers of services in this sector, that are subject to proof that they are meeting relevant national and international statutory requirements. Furthermore, the standard is directed at service providers and suppliers oriented within the value chain which according to customer requirements have to demonstrate their performance.
With a Canadian authorities recognized CMDCAS Certificate according to ISO 13485, manufacturer may receive for their medical devices Hazard Classes II, III and IV according to the Canadian MDR (Medical Device Regulation) approval for the Canadian market. Besides the typical medical device manufacturers, for example manufacturers of electric toothbrushes are also affected by that.
DQS MED is one of the few notified bodies worldwide that is authorized to issue ISO 13485 certificates according to the requirements of the Canadian Medical Devices Conformity Assessment System. Since October 2003, DQS MED is accredited and listed by the Canadian Licensing Authority Health Canada as an official CMDCAS recognized registrar. ISO 13485 Certification is useful to companies that develop, manufacture and distribute medical devices, also to demonstrate their competitiveness and performance on the national and international markets and to increase their reputation in the public. A certified according to ISO 13485
- demonstrates compliance with laws and regulations or rather contractual agreements,
- minimizes and control risks,
- emphasizes the competence of the company,
- operates error prevention rather than error correction,
- improves the quality of performance
- increase customer and employee satisfaction,
- provides transparency and clarity of internal processes and
- saves time and costs.