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15:53 Feb 8, 2009
English to English translations [PRO] Medical - Management
ISO, EU & FDA Regulatory Affairs Consultants
ISO registration and certification consulting services for ISO 13485:2000, ISO 13488:2000 and ISO 9001 compliance, EU MDD (European Union Medical Device Directives), IVDD and AIMDD, IEC 60601-1 and IEC 61000-1 (-1, 2, 3, 4, 5, 6 & 8) EMC. Registration, certification and compliance certificate consultants providing assistance with FDA regulatory and notified body inspections and audits. Implementation of QSRs (FDA Quality System Regulations) and GMP standards.
EU Medical Device Directives
EU (European Union) Directives (required for medical devices) are:
AIMDD Active Implantable Medical Devices Directive (permanently implanted devices)
IVDD In Vitro Diagnostic Directive (diagnostic devices and kits)
MDD Medical Devices Directive (for other medical devices)