Medtech distributor Salient Medical Solutions (Toronto) said it has received ISO 13485:2016 Medical Device Single Audit Program (MDSAP) certification for Medical Device and Quality Management Systems (QMS).
While most manufacturers have 13485:2016 certification, Canada is currently the only country to make MDSAP mandatory as of January 1, 2019. MDSAP certification is meant to assure medical device contract manufacturers of working with a distributor that can find a safe and compliant route into the marketplace.
ISO 13485:2016 is an internationally recognized quality standard that specifies the requirements of a company’s QMS to provide sales, service and distribution of medical devices that consistently meet both customer and regulatory requirements. The certification is obtained through extensive auditing by a recognized auditing organization, following many months of planning and execution.
“We see the ISO 13485:2016 standard as an extremely effective QMS model, and our certification demonstrates Salient’s successful compliance with medical device industry regulations and standards required of the Canadian medical marketplace,” said Salient president Jay Herman in a news release.
“This achievement represents an important milestone and demonstrates our ‘quality-first’ approach to operations, as well as a commitment to providing high-quality products and service to our clients,” added company CEO Michael Pizzorno. “We are very proud of the team and the hard work that led to this significant accomplishment for Salient”.
Salient distributes medical technology products for hair, body, skin and eye treatments. The company also provides clients with in-house technical support and education, marketing plans and medical practice business development.