Essays about: "Medical device regulation"

Showing result 6 - 10 of 14 essays containing the words Medical device regulation.

  1. 6. Adoption of Additive Manufacturing in the Medical Industry within Sweden : Stakeholder analysis in the process of adoption of AM in the medical industry and their influence on each other

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

    Author : Sairaj Parasa; Mohammed Abujan Rehman Basha; [2021]
    Keywords : Additive manufacturing; stakeholders’; stakeholder analysis; adoption of new technology; medical industry.;

    Abstract : Additive manufacturing (AM) is a printing technology which can produce 3-dimensional solid object by adding layers of material from 3D model data. AM has numerous benefits and can bring a new industrial revolution. To have a smooth transition in the technology, organizations must consider involved stakeholders’ interests. READ MORE

  3. 7. The curious case of artificial intelligence : An analysis of the relationship between the EU medical device regulations and algorithmic decision systems used within the medical domain

    University essay from Uppsala universitet/Juridiska institutionen

    Author : Pernilla Björklund; [2021]
    Keywords : medical device; algorithmic decision systems; ADS; MDR; medical AI;

    Abstract : The healthcare sector has become a key area for the development and application of new technology and, not least, Artificial Intelligence (AI). New reports are constantly being published about how this algorithm-based technology supports or performs various medical tasks. READ MORE

  4. 8. The Medical Device Regulation : What Impact Will the New Regulation Have on the Medical Device Industry and How Will Companies Use Standards to Meet the New Requirements

    University essay from KTH/Medicinteknik och hälsosystem

    Author : Emelie Thunborg; Emma Österberg; [2021]
    Keywords : Medical Device Regulation; MDR; Swedish Institute of Standards; European Commission; Standardization; Standards; CE marking; Notified body; Medical Technology; Medicinteknisk förordning; MDR; Svenska Institutet för Standarder; Europeiska kommissionen; Standardisering; Standarder; CEmärkning; Anmält organ; medicinteknisk utrustning;

    Abstract : The New Medical Device Regulations (MDR) will become affective on 26 May, 2021. The new regulation entails higher requirements for companies that develop medical devices, but also for all parties involved in the medical device industry. READ MORE

  5. 9. The Impact of Medical Devices Regulations on Notified Bodies and Additive Manufacturing

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

    Author : Jianing Qi; Shilun Wei; [2020]
    Keywords : Medical device regulation; Notified Bodies; Additive Manufacturing; Additive Manufacturing in healthcare;

    Abstract : The medical device regulatory system, as well as the medical device market in the European Union (EU), is now facing challenges posed by the newest regulation, Medical device regulations (MDR). Researches have shown concerns and possible consequences related to this new regulation system from both the regulatory approval procedure and market development perspectives. READ MORE

  6. 10. Development of Medical Device : A Narrative Literature Review

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

    Author : Azhar Fuadi Siregar; [2020]
    Keywords : product development model; medical device; healthcare;

    Abstract : The Stage-gate model has long been used in product development. Alternatives to Stage-gate such as Design Thinking and other models have been developed which are flexible and consider users’ needs early on and thus they could be more suitable for medical device development. READ MORE