- Main Navigation
- Products + Services
- Certificates + IDs
ISO 13485/CMDCAS (Medical Devices)
ISO 13485
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) that will come into force in Japan in 2005 will require a legally registered manufacturer and ensuring confirming the quality system on the basis of ISO 13485.
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.
CMDCAS
The Canadian authority requires ISO 13485/8 quality system certification if you want to obtain a medical device license for class 2 and higher products.
TUV Rheinland of North America has been accredited by Canadian SCC (The Standards Council of Canada) as the CMDCAS registrar who can perform audits and issue registrations to ISO 13485/8 under the CMDCAS.