Capillus Earns ISO 13485 Certification Through Single Audit Program Pilot

Capillus LLC, a medical device manufacturer focused on hair loss treatment, 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 that 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 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.
 
“After 30 years in the product manufacturing industry, I’ve never worked for a more proactive and quality conscious company than Capillus,” said Patricia Schnoor, Capillus’ director of quality and regulatory Affairs. “Capillus is devoted to having a strong quality support system that protects the best interests of the customer and the company.”
 
Capillus’ certification process was completed by Intertek, a provider of 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 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.
 
Capillus is a Miami, Fla.-based medical device manufacturer & marketer of solutions for hair loss. Founded in 2012, the company is a resource for those battling hair loss. Capillus LLC serves the physician and the consumer market with medical laser devices and cosmetic products. The company also connects patients to hair transplant surgeons and dermatologists for both surgical and non-invasive treatment options. Capillus received its first FDA 510(k) clearance in January of 2015. Capillus has been manufacturing its medical laser devices since January 2015. The company moved to its current 20,000-square-foot location in the area of Doral, Fla., to expand its manufacturing facilities in June of 2015 and has been experiencing steady growth with a total of five FDA 510(k) clearances for its four laser therapy models.