Test-Drive the New Isolated High-Power Stimulator
ViroMax High-Efficiency Viral Bacterial Filter
A-M Systems has developed its quality management system in compliance with ISO 13485:2016, U.S. FDA Quality System Regulations (21 CFR PART 820), EU Medical Device Regulations (MDR 2017/745), Canada Medical Device Regulations (SOR/98-282), and many other relevant regional regulatory requirements. A-M Systems will focus management review efforts on continual improvement of our quality system.
| United States | FDA 510(k) Cleared/PMA Approved Devices View FDA Database Device Listings |
| Declarations of Conformity | Nose Clips Disposable Rubber Mouthpieces Reusable Rubber Components |
| European Authorized Representative | Swiss Authorized Representative | Notified Body / Registrar |
| MedEnvoy Global Prinses Margrietplantsoen 33 Suite 123 2595 AM, The Hague The Netherlands Tel.: +31 (70) 326.2148 | MedEnvoy Switzerland Gotthardstrasse 28 6302 Zug Switzerland Tel.: +41 (41) 562.0142 | BSI Management Systems America, Inc. 12110 Sunset Hills Road, Suite 200 Reston, VA 20190-5902 U.S.A. Tel.: +1 (800) 862-4977 |
