Essays about: "Medical device regulation"

Showing result 11 - 14 of 14 essays containing the words Medical device regulation.

  1. 11. MDR 2017/745 - New EU Regulation for Medical Devices: A Process Description for EHR Manufacturers on How to Fulfill the Regulation

    University essay from KTH/Medicinteknik och hälsosystem

    Author : Frida Germundsson; Nicole Kvist; [2020]
    Keywords : MDR; regulation; process description; EHR system; CE mark; medical technology;

    Abstract : On the 26th of May 2021 the new regulation for medical devices, MDR 2017/745, will come into force. The underlying incentives to go from the medical device directive (MDD 93/42/EEC) to MDR are a series of adverse events involving medical devices. READ MORE

  3. 12. Additive Manufacturing in Orthopedics and Craniomaxillofacial Surgery for the Development of High-risk Custom-made Implants : A Qualitative Study of Implementation Factors from a Multi-stakeholder Perspective

    University essay from Uppsala universitet/Industriell teknik

    Author : Antonia Evgenia Nioti; [2020]
    Keywords : Implementation; CFIR; custom-made implants; barriers; surgery; disruptive innovation; additive manufacturing; 3D printing; medical device regulation; ortopedics; craniomaxillofacial; Implementering; patientspecifika implantat; disruptiva teknologier; additiv tillverkning; ortopedi; käkkirurgi; kraniokirurgi; regelverket; hindrande och underlättande faktorer;

    Abstract :   Additive manufacturing (AM) has enabled the possibility for the hospitals to become their own implant producers developing implants that are tailored to patient’s anatomy. Despite the enormous potential of custom-made implants there are challenges that complicate the implementation of them into clinical practice. READ MORE

  4. 13. The applicability of modelling and simulation : A case study within the medical device industry

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

    Author : Anton Nyström; David Hellberg; [2020]
    Keywords : medical device industry; modelling and simulation; continuous improvement; regulation; bottleneck analysis;

    Abstract : The medical device industry has for a long time lagged behind other industries in terms of adopting new tools for process improvements. Despite showing promising results from various industries, some more heavily regulated than others, modelling and simulation has not yet gained traction within the medical device industry for performing production improvements. READ MORE

  5. 14. Risk Management in Medical Devices: Hazard Identificationand Verification of Mitigation Controls

    University essay from KTH/Medicinteknik och hälsosystem

    Author : Gislé Segura Roca; [2020]
    Keywords : ;

    Abstract : 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