Essays about: "ISO 14971"

Found 2 essays containing the words ISO 14971.

  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; 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

  2. 2. Risk Management in MedicalDevices: Hazard Identificationand Verification of MitigationControls

    University essay from KTH/Medicinteknik och hälsosystem

    Author : Gislé Segura Roca; [2020]
    Keywords : ;

    Abstract : During this project, the risk management of a medical device under development that deals with drug administration has been done. The aim of the project is to evaluate if part of the device is safe according to the current regulations in Sweden. READ MORE