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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 556-1:2001/AC:2006 Standard
This standard is a correction for "EN 556-1:2001"
Active implantable medical devices Directive (90/385/EEC)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...
Active implantable medical devices Directive (90/385/EEC)
Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
Active implantable medical devices Directive (90/385/EEC)
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Active implantable medical devices Directive (90/385/EEC)
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
Active implantable medical devices Directive (90/385/EEC)
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
Active implantable medical devices Directive (90/385/EEC)
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, vali...
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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