Certification in Accordance with EN ISO 13485 (and EN ISO 9001)
This international standard for quality management systems for companies in the field of medical devices defines the requirements for QM systems for the design and development, production, customer care, and installation of medical devices. It covers fundamental GMP (Good Manufacturing Practice) principles, which normally apply during the manufacture of medical devices. Request a free quote today.
CMDCAS – Canadian Medical Device Conformity Assessment System
Companies that manufacture and/or sell medical devices in Canada must conform to CMDCAS, the purpose of which is to ensure that the companies are actually complying with the quality systems requirements of the Medical Device Regulations. All medical device companies that submit an application for a Class II, III, or IV medical device must also submit a valid quality system certificate issued by a CMDCAS recognized registrar, such as TUV Rheinland of North America.