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  • Developing of Biobsorbable Implantable Device

    9 August 2015 0 Comments

    Posted in:
    • Biological Evaluation
    • Biopolymer Testing
    • Design
    • FEM Simulation
    • Industry
    • IQ OQ PQ Validation
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    • Medical Device
    • Molding
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MDR Guidelines

Implementation of Medical Devices EU-Regulation – Focus on Manufacturers’ obligations

Implementation Model for Medical Devices Regulation Step by Step Guide

Fact Sheet for Manufacturers of Medical Devices

Implementation Model for In-Vitro Diagnostic Medical Devices Regulation: Step by Step Guide

Fact Sheet for Manufacturers of In-Vitro Diagnostic Medical Devices

TÜV SÜD – Fact Sheet

MHRA -MDR – IVDR Guidance

MDR Training Resources

- Regulation 745/2017 on Medical Devices: main changes and timeline to implementation

- Regulation 745/2017 on Medical Devices: obligations of the economic operators, from Eudamed registration to Responsible person

- Regulation 745/2017 on Medical Devices: Unique Device Identification

- Regulation 745/2017 on Medical Devices: Technical File structure

- Regulation 745/2017 on Medical Devices: Post Market activities and follow up

Wordwide regulation resources

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