QUALITY CREDENTIALS
-
The AB Medical Technologies, Inc. quality system complies with the following standards:
-
International Standard ISO 13485:2003 Click here for certificate
-
California State FDA QSR Requirements. Click here for license
-
Our
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:
-
FDA Quality System Regulation (QSRs) 21 CFR 820
-
European Community Medical Device Directive (MDD) 93/42/EEC
-
International Standard ISO 14971:2007, 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.
-