ISO 13485/CMDCAS

ISO 13485:2003 - Medical Device QMS

ISO 13485:2003 - Medical device- Quality management systems- Requirements for regulatory purposes has been published. ISO 13485 is the quality management system standard for design & development, production, selling and other activities of medical devices. It is internationally used as regulatory requirement for the medical devices, e.g., in EU, Canada, Australia. Revised Pharmaceutical Affairs Law (PAL).

TUV Rheinland has globally performed ISO 13485 certification for leading medical device manufacturers. TUV Rheinland performs ISO 13485 certification as required in the revised PAL.

The Canadian Medical Device Conformity Assessment System (CMDCAS)

The Standards Council of Canada (SCC) has accredited TUV Rheinland of North America to perform audits and issue registrations to ISO 13485/8 under the Canadian Medical Device Conformity Assessment System (CMDCAS) sector. This is a great achievement and qualifies TUV as a CMDCAS recognized registrar.

As of January 1, 2003, an ISO 13485/8 certificate from a CMDCAS recognized registrar will be a mandatory element of any device license application that needs to be filed with Health Canada. This certificate will also be mandatory for the annual renewal of Canadian Medical Devices Licenses as of November 2003.

We commit to quality and to guide you through the certification process in accordance with ISO 13485/8 in order to create transparency and comprehensibility for all processes.

With our online webpage TUVdotCOM, it's so easy to find companies with both ISO 13485/8 an ISO 13485/8 certificate from a CMDCAS recognized registrar certified by TÜV Rheinland Vietnam.