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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 10993-3:2014 Standard
Active implantable medical devices Directive (90/385/EEC)
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
Active implantable medical devices Directive (90/385/EEC)
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...
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)
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...
Active implantable medical devices Directive (90/385/EEC)
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...
Active implantable medical devices Directive (90/385/EEC)
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation an...
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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