Sökning: "NBRG Consensus paper"

Hittade 1 uppsats innehållade orden NBRG Consensus paper.

  1. 1. Evaluating the Compliance Re-Certification Efficiency Enabled by the AMASS Platform for Medical Devices

    Magister-uppsats, Mälardalens högskola/Akademin för innovation, design och teknik

    Författare :Aleksandër Pulla; Antonela Bregu; [2020]
    Nyckelord :AMASS project; certification; re-certification; efficiency; medical devices; ISO 14971; NBRG Consensus paper; reuse; standard; tool-chain; metrics; directives; regulations;

    Sammanfattning : The certification of systems in the medical domain aims to ensure that a system is acceptably safein order to bear the CE mark. Such process is exhaustive, expensive, time-consuming and safety-critical.Medical devices shall be re-certified under Medical Device Regulations. LÄS MER