CAPILLUS EARNS ISO13485 CERTIFICATION FOR USA AND CANADA THROUGH THE MEDICAL DEVICE SINGLE AUDIT PROGRAM PILOT
Capillus, a manufacturer of hair-loss solution products, is among the first to receive certification through the program
MIAMI, FLA. SEPTEMBER 15, 2016- Capillus, LLC, a medical device manufacturer focused on providing customers with the best products in treatment for hair loss, today 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.
“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 & Regulatory Affairs. “Capillus is truly devoted to making the best product possible, as well as having a strong quality-support system that protects the best interests of both the customer and the company.”
Capillus’ certification process was completed by Intertek, a world leader 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 utilizing laser diodes for hair (re)growth promotion.
To learn more about laser hair restoration with Capillus, visit our website, www.Capillus.com, or call directly at 888-272-9599.”
ABOUT CAPILLUS, LLC
Capillus, LLC is a Miami-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 & dermatologists for both surgical & non-invasive treatment options.
Capillus was founded in October 2012 and 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 present day 20,000 square foot location in the area of Doral to expand its manufacturing facilities in June of 2015 and has been experiencing steady growth with a total of 5 FDA 510(k) clearances for its four laser therapy models.
Building on its mission to provide customers with the best products in treatment of hair loss, all Capillus products cater to both women & men with thinning hair or at risk for thinning hair, a condition that affects up to 50% of adult women & 80% of adult men.
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