Capillus, a medical device manufacturer focused on providing customers with the best products in treatment for hair loss, announced that it is one of the first companies in the world to receive ISO 13485:2003 certification for its quality management system through the Medical Device Single Audit Program (MDSAP) pilot.
MDSAP is an international initiative led by a group of Regulatory Authorities, including the U.S. Food and Drug Administration (FDA) and Health Canada, aimed at developing, managing and overseeing a single audit program that makes worldwide medical device regulation easier and more effective.
Medical device manufacturers who participate in the program are subject to rigorous audits performed by approved MDSAP Auditing Organizations. This certification process tests companies’ manufacturing facilities and quality management systems (QMS).
The Capillus factory was inspected to ensure that it met current Good Manufacturing Practices set by the FDA. Moreover, the QMS was thoroughly evaluated to check that every detail—from the creation process to employee training—met the program’s high standards. Since the standards set by the MDSAP pilot program process meet or exceed expectations in most countries, this certification additionally grants Capillus greater global access.
Capillus’ certification process was completed by Intertek, a developer in total quality assurance, and one of the Auditing Organizations authorized by the participating Regulatory Authorities to audit under the MDSAP pilot.
Capillus is the only manufacturing and design company of its size to participate in Intertek’s rigorous MDSAP program, as well as the only company specializing in laser therapy for hair regrowth. Intertek’s certificate confirms the company’s conformance to the requirements of ISO 13485:2003, Canada : Medical Devices Regulations – Part 1- SOR 98/282 and United States : 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 (Subparts A to D). The scope of the audit encompasses the design and development, manufacture, service and support of devices using laser diodes for hair (re)growth promotion.