A-M Systems Quality Systems and Regulatory Compliance

A-M Systems Quality Systems 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.

Quality Management System

13485:2016 Quality System Certification
US FDA Good Manufacturing Practice (GMP)
- We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations.
A-M Systems Quality Manual

Product Certifications and Approvals

United States	FDA 510(k) Cleared/PMA Approved Devices View FDA Database Device Listings
Declarations of Conformity	Nose Clips Rubber Mouthpieces

Global Regulatory Representatives

European Authorized Representative	Notified Body / Registrar
Emergo Europe Prinsessegracht 20 2514 AP, The Hague The Netherlands Tel.: +31 (70) 345.8570	BSI Management Systems America, Inc. 12110 Sunset Hills Road, Suite 200 Reston, VA 20190-5902 U.S.A. Tel.: +1 (800) 862-4977

A-M Systems Quality Systems and Regulatory Compliance

Quality Management System

Product Certifications and Approvals

Global Regulatory Representatives

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