Essays about: "re-certification"

Found 1 essay containing the word re-certification.

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

    University essay from Mälardalens högskola/Akademin för innovation, design och teknik

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

    Abstract : 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. READ MORE