A-M Systems Quality Systems and Regulatory Compliance
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
Product Certifications and Approvals
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
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