Essays about: "medical device regulation"

Showing result 1 - 5 of 14 essays containing the words medical device regulation.

  1. 1. 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

  3. 2. Design and Implementation of a Digital Traceability System of Implantable Pacemakers in the Care Process

    University essay from KTH/Medicinteknik och hälsosystem

    Author : Emma Skärvinge; [2022]
    Keywords : Implantable Pacemaker; Digital Traceability; Unique Device Identification; Healthcare Process; Patient Safety; Implanterbar pacemaker; digital spårbarhet; unik enhetsidentifiering; vård-process; patientsäkerhet;

    Abstract : A major problem in healthcare today is the manual handling of administrative work. Few processes are automated and healthcare professionals are forced to spend a lot of time on paperwork, which means that their time with patients suffers. This has a major negative impact on patient safety. READ MORE

  4. 3. 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

  5. 4. 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

  6. 5. 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