QUALITY & TRACEABILITY: At Capillus, we are proud to say that each one of our laser devices is made in the USA from foreign-source raw materials at our new 20,000 square foot ISO 13485 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 ISO 13485:2003 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 & 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.
Capillus laser devices are proudly manufactured in the United States of America. Join Capillus CEO, Carlos Piña and Head of Quality Assurance and Regulatory Affairs, Patricia Schnoor, for this exclusive look inside the Capillus laser products manufacturing center in Miami, Florida.
Hello, my name is Carlos Piña, I’m the CEO of Capillus. I am here today to give you a brief tour of our manufacturing facilities, here in the United States in the city of Miami. And you will hear also from the head of quality assurance and governmental affairs, Ms. Patricia Schnoor.
My name is Patricia Schnoor, I came to Capillus in December of last year after spending 4 years in Europe. I’m very happy to be back home in Miami, and to have found a job so close to home here. I’ve been in medical devices in one way or another for over 30 years. Prior to Capillus, I was with Philips. So when I came here, the idea was that I would take care of the quality assurance and regulatory affairs. So the first thing we did was make sure we have a fully operating quality system, compliant to the FDA regulation 21 CFR. Then we added on to that the international regulation, ISO 13485, as well as committing to participate in the new program MDSAP, Medical Device Single Audit Program. The reason for our very nice manufacturing facility and our full compliance to quality regulations worldwide is in order to produce a safe and effective device that has been reviewed by the FDA for safety, efficacy, and compliance to regulation as far as lasers and other items go. We have an excellent reputation with our distributors. We provide caps through a network of health care professionals. We want the public to be assured when they buy and use the product that they have confidence that it is appropriate for them, and they can expect good results over time.
This is important because most of the medical device products that are being sold in the United States are being manufactured in Asia, basically in China. Our product is a FDA 510 cleared device in the United States, and we also sell the product in the European community, as well as in the rest of the world.