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  • Developing of Biobsorbable Implantable Device

    9 Agosto 2015 0 Comments

    Posted in:
    • Biological Evaluation
    • Biopolymer Testing
    • Design
    • FEM Simulation
    • Industry
    • IQ OQ PQ Validation
    • Mechanical
    • Medical Device
    • Molding
    • Pharma
    • Reverse Engineering
    • Sterilization Process and Validation
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biological evaluation corsi mdr dispositivi medici gap assessent mdr iso 10993 iso 10993:2018 nuova iso 10993 regole di classificazione dispositivi medici test biocompatibilità valutazione biocompatibilità valutazione sicurezza biologica

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

Recent Posts

  • NUOVA ISO 10993-1: 2018 – Valutazione Biocompatibilità Dispositivi Medici – Cosa Cambia?
  • MDR VS MDD e Riclassificazione Dispositivi Medici
  • NUOVO REGOLAMENTO DISPOSITIVI MEDICI 2017/745

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