A-M Systems Quality Systems and Regulatory Compliance

A-M Systems Quality SystemsA-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.


Quality Management System

Product Certifications and Approvals

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


Global Regulatory Representatives

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

Tel.: +41 (41) 562.0142
BSI Management Systems America, Inc.
12110 Sunset Hills Road, Suite 200
Reston, VA 20190-5902

Tel.: +1 (800) 862-4977