Lexington Int'l Achieves MDSAP & ISO-13485:2016 Certification of HairMax Laser Hair Growth Devices

BOCA RATON, Fla. - Aug. 28, 2018 - PRLog -- Lexington Int'l pioneered the home use of laser phototherapy for the treatment of hereditary hair loss in 2007 and has always met the highest quality standards of design and manufacturing. This latest MDSAP and ISO 13485:2016 certification from Intertek Testing Services NA, Inc. further indicates that the company's quality management systems meets the specific standards required for the design and manufacturing of low level laser medical device used to promote hair growth.  ISO 13485-2016 for medical devices is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.  This certificate opens the market for Canada beginning 2019 and it will open other doors in the international markets as well including Brazil and Australia.   It demonstrates Lexington's commitment to a proper industrial approach through the adoption of international quality standards and demonstrates the company's ability to market medical devices that have the highest quality standards.

Mr. Sergio Borjas, Quality Systems and Regulatory Compliance Manager at Lexington said: "Achieving Medical Device Single Audit Program, MDSAP and ISO 13485:2016 certification is the result of over one year of continuous efforts. It indicates that HairMax has taken the necessary steps to be compliant with globally harmonized regulatory requirements that govern the development, manufacturing and post-market activities of our devices in the US and main international markets."

About Lexington International, LLC

Based in Boca Raton, Lexington Int'l is the global leader in laser hair growth technology. HairMax Laser devices are the first device on the market to receive FDA Clearance as a medical device to treat hair loss and stimulate hair growth. HairMax devices have been the subject of 7 clinical studies proving both efficacy and safety with an over 90% success rate. Today, HairMax laser devices hold 8 FDA clearances and 14 medical device licenses world-wide.  Sold in over 170 countries, HairMax has helped over 1.4 million men and women, treat their hair loss and enrich their lives.

For more information please visit: www.hairmax.com