California Sunset

530-605-2522       20272 Skypark Dr.      Redding, CA 96002

sales@abmedtech.com  See Our Clean Room Page

QUALITY CREDENTIALS

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

    • International Standard ISO 13485:2003   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

       

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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.