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  • Biological Evaluation of Dental Device

    4 May 2015 0 Comments

    Posted in:
    • Biological Evaluation
    • Dental
    • Industry
    • Medical Device
    Tagged with:
    • Biological Evaluation
    • Dental Device Biological Safety
    • ISO 10993
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  • Biological Safety Evaluation

    19 April 2015 Comments are off

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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

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  • India Regulatory Framework Medical Device registration
  • Hong Kong Regulatory Framework Medical Device registration

Recent Posts

  • Importance of CEP/CER, PSUR, PMCF in the Regulatory Compliance of Medical Devices
  • Decentralized clinical trials (DCTs) with Medicinal Products in Switzerland – Position Paper
  • Medical Devices – US FDA Regulations Versus EU MDR
  • ISO 11608 – Testing Protocols for Needle Based Injection Systems (NISs)
  • The UKCA Marking – Access the UK Market

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