530-605-2522 20272 Skypark Dr. Redding, CA 96002
The AB Medical Technologies, Inc. quality system complies with the following standards:
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.