TUV Rheinland Accredited By SCC

Newtown-based TUV Rheinland of North America, Inc, a global leader in regulatory compliance testing and certification, has been accredited by the Standards Council of Canada (SCC). This accreditation permits TUV Rheinland as a CMDCAS (Canadian Medical Devices Conformity Assessment System) recognized registrar to perform audits and issue registrations to ISO 13485/8 under the CMDCAS sector qualification.

Heinz-Joerg Steneberg, TUV Rheinland’s medical division manager, said, “Most medical device manufacturers in the United States traditionally look to Canada when they consider entering foreign markets. We are now able to offer CMDCAS to these companies.”

In order to sell medical devices in Canada, Health Canada requires all manufacturers of class II, III and IV devices to have their quality system certified to the ISO 13485/8 standard by a CMDCAS recognized registrar. On January 1, 2003, ISO 13465/8 registration became a mandatory element of any medical device license application filed with Health Canada.

The registration will also be mandatory for the annual renewal of Canadian Medical Device licenses beginning November 2003.

TUV Rheinland of North America, Inc (TRNA) is a subsidiary of TUV Rheinland Berlin Brandenburg and is a global leader in compliance engineering, testing, and certification for domestic and foreign markets.

The company has offices in San Francisco, Chicago, Detroit, Boston, Raleigh, Austin, Portland, Calgary, Toronto, and Mexico City. For more information about TRNA’s medical device related services, visit the company website at www.us.tuv.com.