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Useful
WEBSITES
Click to access the website AAMI (Association for the Advancement of Medical
Instrumentation) AFNOR
ONLINE (French Agency for
Normalization) AFSSAPS (French Sanitary Autority) ASTM (American Society for Testing and Materials) CDRH DATABASE (Center for Devices and Radiological
Health) GHTF Global Harmonization
Task Force HAS French Health Autority ISO (International Standard Organization) IVS French Sanitary Vigilance Agency Useful
documents to download
2005/50/EC DIRECTIVE on the reclassification of hip, knee and
shoulder joint replacements Download 93/42/EC DIRECTIVE related to Medical devices Original
version Consolidated
version including Dir 2007/47 98/79/EC DIRECTIVE related to In vitro Diagnostic medical
devices Original
version Consolidated
version CANADIAN REGULATION Medical devices regulation Download COMPETENT AUTHORITY EUDAMED (France) France Establishment and device registration for class I medical
devices Notice
Form FDA GUIDANCE Guide to inspections of medical device manufacturers Download FDA GUIDANCE Guide to Inspections of Quality Systems Download FDA GUIDANCE Medical device quality systems manual:A
small entity compliance guide Download FREE GHTF Guidances related to medical devices Download HARMONIZED STANDARDS Dir93/42 Download IN VITRO DIAGNOSTIC France Establishment and device
registration Notice
Form
A Form
B Form
C MATERIOVIGILANCE (France) Form Download MEDDEV Medical devices guidances edited by European community Download MEDICAL DEVICES FRANCE Pre market notification for high risk
medical devices Decree Notice
Form NB-MED Medical devices guidances edited
by notified bodies Download REACTOVIGILANCE (France) Guide
Form
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