Quality & Traceability: At Capillus, we are proud to say that each one of our laser devices is made in the USA from foreign-sourced raw materials at our new 40,000 square-foot ISO13485-compliant manufacturing facility in Miami, Florida, allowing for complete control of the quality of our product.
We are focused on providing customers with the best products in treatment for hair loss and are proud to be among the first companies worldwide to receive ISO13485:2003 certification for our quality management system through the Medical Device Single Audit Program (MDSAP) pilot, an international initiative led by a group of Regulatory Authorities, including the U.S. Food and Drug Administration (FDA) and Health Canada. Capillus meets current Good Manufacturing Practices set by the FDA and can provide Certificates to Foreign Governments upon request for importing.
Every single unit is inspected before shipping according to our quality system to ensure that each product that leaves Capillus meets FDA and ISO regulatory standards, as well as those placed on ourselves to meet the needs of our customers. All repairs are handled by our service technicians located in our Miami, Florida, headquarters. Manufacturing in the USA also gives us more flexibility to innovate and make product improvements quickly.
At Capillus, we are committed to meeting customer requirements and enhancing customer satisfaction through continual improvement of our products, services, and quality management system.
