BIOMATCAN Achieves ISO 13485-2016 with MDSAP Certification

Shawni Beaulieu October 18, 2018

Fredericton, New Brunswick, October 17, 2018BIOMATCAN Ltd announces today that it has successfully updated its quality system ISO 13485-2003 to the latest version: ISO 13485:2016 certification including Medical Device Single Audit Program (MDSAP) standard. This new upgrade confirms that BIOMATCAN Ltd meets all regulatory requirements in the U.S., Canada, for medical device design, development, manufacturing and distribution.

Audited by Intertek Testing Services; one of the leading global certification organizations, BIOMATCAN’s new certification places a greater emphasis on the excellence of its QMS throughout the supply chain and product life cycle, as well as device usability and post-market surveillance requirements. In the highly competitive industry of medical device manufacturing, adhering to the latest ISO certification standard is essential to delivering innovative, high-quality medical products to users around the globe.

The International Organization for Standardization (ISO) is a non-government entity comprised of academic and industry professionals that certify companies are compliant with industry-standard best practices in their production and operations.

Introduced in 2014, MDSAP certification requires that the recipient pass an extensive auditing process to prove its existing quality management system meets the requirements set forth by governing bodies in the U.S., Canada, Brazil, Japan and Australia for the design and manufacture of medical devices.

Medical device manufacturers are required by Health Canada and other international governing health authorities to update their quality systems to the new standard using the MDSAP program by March 2019 in order to remain in compliance. The ISO 13485:2016 standard for quality management systems places an increased emphasis on risk management and also aligns more closely with the FDA’s Quality System Regulations for medical device companies manufacturing or selling products into the United States.


Established in 2011, BIOMATCAN Ltd is a Canadian Leader in Design Development and Manufacturing of high-quality medical devices Bone-like Biomaterials for Orthopedic, Dental and Animal Health.


Unit 3, 385 Wilsey Road

Fredericton, E3B 5N6,

NB, Canada.

Tel: 1506-450 0404

Fax: 1506 450 0405

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