TORONTO, May 30, 2019 – Salient Medical Solutions Inc., a leading distributor of world-class medical technology, announced today it received ISO 13485:2016 MDSAP certification for Medical Device and Quality Management Systems (QMS).
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. While most manufacturers have 13485:2016 certification, Canada is currently the only country to make the Medical Device Single Audit Program (MDSAP) mandatory as of January 1, 2019. With its MDSAP certification, contract manufacturers of medical devices can rely on Salient to find a safe and compliant route into the growing Canadian marketplace.
“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 Jay Herman, President of Salient.
“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,” Said CEO Michael Pizzorno. “We are very proud of the team and the hard work that led to this significant accomplishment for Salient”.
Salient’s high-quality product lineup represents the forefront of medical technology and includes products for hair, body, skin, and eye treatments. In addition, Salient provides in-house technical support and education, marketing plans, and medical practice business development models for clients.