Integrity Life Sciences Earns Canadian Stamp of Approval

Integrity Life Sciences has earned the Canadian Medical Devices Conformity Assessment Scheme (CMDCAS) certification, which acknowledges the company’s “continued commitment and responsibility to its global partners and ensures that devices marketed and sold in Canada will be safe, effective and of high quality,” according to Integrity.

Health Canada requires medical device manufacturers to obtain not only an ISO:13485 quality system certificate, but further evidence of compliance with Canada’s Medical Device Regulations (MDR). Compliance with Canada’s MDR results in a CMDCAS certificate issued exclusively by registrars certified by Health Canada to perform CMDCAS audits.

Selling in Canada is a multistep process that begins with passing a CMDCAS quality audit and obtaining the requisite CMDCAS certificate. To sell a medical device in Canada, manufacturers must meet the regulatory requirements as defined in the Canadian Medical Devices Regulations and obtain a license to sell within the country. Manufacturers of Class II, III, and IV medical devices must obtain a license before selling in Canada attesting to their respective quality system under which their devices are manufactured. MDR requires that medical device manufacturers prove the devices they market or sell are safe, effective and meet the necessary quality standards.

“The registration of the quality management system governing our design and development of the Integrity spinal care systems provides Integrity with yet another independent third-party validation of our systems and processes,” said James Gibson, president of Integrity. “It also reflects Integrity’s commitment to customers to ensure our technology continues to meet and exceed the highest international regulatory standards.”

Integrity Life Sciences is based in Tampa, Fla. The company focuses on technology that treats chronic low back and neck pain.