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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 ISO 13485:2016/AC:2018 Standard
This standard is a correction for "EN ISO 13485:2016"
Active implantable medical devices Directive (90/385/EEC)
Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptic...
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)
Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat ta...
Active implantable medical devices Directive (90/385/EEC)
Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat ta...
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)
Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufa...
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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