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This Free of Charge application was designed to help manufacturers, consultants, notified bodies to keep under control the EU declaration of conformity
This software allows you to compose in few minutes declaration of conformity compliant with applicable directives taking under control list of products, declarations of conformity, amended declarations
EN 1041:2008 Standard
Anyway is still possible use the "EN 1041:1998" until August 31st, 2011
Active implantable medical devices Directive (90/385/EEC)
Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)
Active implantable medical devices Directive (90/385/EEC)
Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat br...
Active implantable medical devices Directive (90/385/EEC)
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
Active implantable medical devices Directive (90/385/EEC)
Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
Active implantable medical devices Directive (90/385/EEC)
Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
Active implantable medical devices Directive (90/385/EEC)
Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
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This software allows you to compose in few minutes declaration of conformity compliant with applicable directives taking under control list of products, declarations of conformity, amended declarations