Essays about: "MDR"

Showing result 1 - 5 of 22 essays containing the word MDR.

  1. 1. Mapping Several NIS2 Directive Articles to Technical Specifications for the Healthcare Sector in Sweden

    University essay from Högskolan i Skövde/Institutionen för informationsteknologi

    Author : Iyad Al Khatib; [2023]
    Keywords : ;

    Abstract : Compliance with legal instruments is vital for the survival of any organization or company in the public and private sectors. Non-compliance may result in criminal and financial penalties that can have grave effects on the indicted institution. READ MORE

  3. 2. The Strategic Adoption of Additive Manufacturing in the orthopedic industry in Sweden

    University essay from Uppsala universitet/Institutionen för samhällsbyggnad och industriell teknik

    Author : Louis Bertrand Ndangamira Shema; [2022]
    Keywords : Additive manufacturing; orthopedic; surgeon; framework;

    Abstract : Additive Manufacturing (AM) is another name for rapid prototyping and 3D printing (3DP), an advanced manufacturing technology that creates 3D objects. AM's ability to produce complex shapes in industrial production is one of its chief advantages. READ MORE

  4. 3. MDR’s Impact on Standards Usages and the Relevance for In-house Production of Medical Devices

    University essay from KTH/Medicinteknik och hälsosystem

    Author : Alexander Söderberg; Birante Soumare; [2022]
    Keywords : In-house production; MDR; Reprocessing; 3D-printing; Swedish Institute for Standards; Standards; Egentillverkning; MDR; Reprocessing; 3D-printing; Svenska Institutet för Standarder; Standarder;

    Abstract : The current regulation for Medical Devices (MDR) entered into force on 26 May 2021, which has entailed major changes to relevant legislation for in-house production of medical devices in healthcare. The relevance for updating existing, or the development of new standards is currently not well documented and determined and the aim of this report is to make recommendations for how the development of standards may be improved and how departments of medical technology (DMT) in practice apply standards at in-house production of medical devices. READ MORE

  5. 4. 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

  6. 5. Evaluating the Implementation and Results of EU 2017/745

    University essay from KTH/Medicinteknik och hälsosystem

    Author : Olivia Gustafsson; [2022]
    Keywords : MDR; regulation; implementation evaluation; implementation result; MDR; förordning; implementeringsutvärdering; implementeringsresultat;

    Abstract : The new regulation on medical devices, EU 2017/745, came into force in May 2021 meaning that all economic operators in the industry need to adhere to new, stricter requirements. As there is yet no common practice on how to implement and comply with the new requirements, many struggles with this. READ MORE