Essays about: "ISO 14971"
Found 3 essays containing the words ISO 14971.
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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
University essay from Uppsala universitet/Tillämpad materialvetenskapAbstract : 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. READ MORE
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2. Evaluating the Compliance Re-Certification Efficiency Enabled by the AMASS Platform for Medical Devices
University essay from Mälardalens högskola/Akademin för innovation, design och teknikAbstract : 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
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3. Risk Management in Medical Devices: Hazard Identificationand Verification of Mitigation Controls
University essay from KTH/Medicinteknik och hälsosystemAbstract : 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