Sökning: "ISO 14971"

Hittade 3 uppsatser innehållade orden ISO 14971.

  1. 1. Improvement of Prevas’ AB quality management system according to ISO 13485:2016 : As a parallel project with the fictive development of ViroDetect for Sweden Diagnostics AB

    Uppsats för yrkesexamina på grundnivå, Uppsala universitet/Tillämpad materialvetenskap

    Författare :Sophie Klingspor; Niclas Svensson; [2023]
    Nyckelord :continuous improvement; ISO; ISO 13485:2016; ISO 14971:2020; quality management; quality management system; requirement specification; risk management; ISO; ISO 13485:2016; ISO 14971:2020; kravspecifikation; kvalitetsledning; kvalitetsledningssystem; riskhantering; ständig förbättring.;

    Sammanfattning : Quality management system’s (QMS) describes how organisations control their interconnected processes through four elements defined as quality planning, quality control, quality assurance and quality improvement to achieve quality through stakeholder satisfaction. The International Organization for Standardization (ISO) develops certifiable international standards for quality management. LÄS MER

  3. 2. 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

  4. 3. Risk Management in Medical Devices: Hazard Identificationand Verification of Mitigation Controls

    Master-uppsats, KTH/Medicinteknik och hälsosystem

    Författare :Gislé Segura Roca; [2020]
    Nyckelord :;

    Sammanfattning : 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. LÄS MER