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| A-M Systems has developed its quality management system in compliance with ISO 13485:2003, 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. |
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Europe - Authorized Representative
Emergo Europe
The Hague, NETHERLANDS
Telephone: +31.70.345.8570
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