California Sunset

530-605-2522       20272 Skypark Dr.      Redding, CA 96002  See Our Clean Room Page


  • The AB Medical Technologies, Inc. quality system complies with the following standards:

    • International Standard ISO 13485:2016   Click here for certificate

    • FDA Quality System Regulation (QSRs) 21 CFR 820

      • FDA Registration No. 3010356635

    • California State FDB Medical Device Manufacturing Requirements.

       Click here for license



BSI LogoOur quality system is certified by BSI who is one of the worlds leading certification bodies, with more that 60,000 certified locations and clients in over 100 countries.


  • Our quality system is also written to maintain compliance with the following standards:

    • European Community Medical Device Directive (MDD) 93/42/EEC and associated modifications to this directive.

    • EN ISO 14971:2012 Risk Management

  • We also have expertise in designing equipment to meet the safety requirements of electronic medical devices including:

    • International Standard IEC 60601-1, Requirements for Safety of Medical Electrical Equipment.

    • International Standard IEC 60601-1-2, Electromagnetic Compatibility Requirements for Medical Electrical Equipment.