A-M Systems Quality Systems and Regulatory Compliance
A-M Systems has developed its quality management system in compliance with ISO 13485:2003, U.S. FDA Quality System Regulations (21 CFR PART 820), EU Medical Device Directive (MDD 93/42/EEC), Canada Medical Device Regulations (SOR/98-282), and any 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
Molenstraat 15
2513 BH, The Hague
The Netherlands
Tel.: +31 (70) 345.8570
Fax: +31 (70) 346.7299 | BSI Management Systems America, Inc.
12110 Sunset Hills Road, Suite 200
Reston, VA 20190-5902
U.S.A.
Tel.: +1 (800) 862-4977
Fax: +1 (703) 437-9001
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