International production standards certified by Intertek and FDA.

HairMax® is committed to developing the highest quality hair care medical devices in the world. Every step of design and manufacturing is conducted under strict quality control systems and certified to international standards to ensure that every product is safe, effective and reliable in every country it is sold.

HairMax International, LLC has been awarded ISO 13485:2016 quality system certification by Intertek Testing Services NA, Inc. , a global assessment organization and listed certification body for the Medical Device Single Audit Program (MDSAP).
The certificate confirms that the HairMax® quality management system meets international standards for

“Design, manufacture and service of low-level laser medical devices for hair growth promotion”

HairMax® also meets the quality requirements of medical regulatory agencies in several countries, including:

• USFDA Good Manufacturing Practices (GMP): United States 21 CFR Part 820 Standards
  

• Health Canada: Medical Devices Regulations – SOR 98/282
  

• Australia TGA: Therapeutic Goods (Medical Devices) Regulations 2002
  

• Brazil ANVISA: RDC ANVISA n. 665/2022 and related standards.
  

Every step of the HairMax® process undergoes continuous quality assessment and certification by Intertek Testing Services to maintain the highest manufacturing standards.

🔹 Verify the validity of the certificate at
www.intertek.com/business-assurance/certificate-validation