Essays about: "ISO 13485"

Found 2 essays containing the words ISO 13485.

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

   University essay from Uppsala universitet/Tillämpad materialvetenskap

   Author : Sophie Klingspor; Niclas Svensson; [2023]
   Keywords : 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.;

   Abstract : 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

3. 2. Quality Management Systems in Healthcare : “Implementation of the Medical Device Regulation”

   University essay from KTH/Skolan för industriell teknik och management (ITM)

   Author : Jonah Ejheden; Teodor Tapper; [2022]
   Keywords : MDR; QMS; Implementation; Hospital; ISO 13485; Gap-analysis; ; QMS; MDR; Implementering; Sjukhus; ISO 13485; Gap-analys; ;

   Abstract : This study investigated how a QMS that is compliant with the Medical Device Regulation (MDR) can be constructed and what the most important aspects are when creating a functional QMS at a Swedish hospital. QMS:s are a fundamental part of a healthcare organization and are used to ensure safe and secure patient care. READ MORE