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  1. 1
    Malaysian Medical Device Regulation for Artificial Intelligence in Healthcare: Have all the pieces fallen into position?
    Subjects: “...Artificial Intelligence and Medical Device Regulation...”
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    Article
  2. 2
    Will the EU Medical Device Regulation help to improve the safety and performance of medical AI devices?
    by Niemiec, E.
    Published 2022
    Subjects: “...Medical device regulation...”
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    Article
  3. 3
    Medical Device Regulation and current challenges for the implementation of new technologies
    Subjects: “...medical device regulation...”
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    Article
  4. 4
    The Medical Device Regulation for Humanoid Robotics: Does One Size Fits All?
    by Fikriah, NS, Ismail, Z, Saripan, H
    Published 2015
    Subjects: “...medical device regulation...”
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    Article
  5. 5
    On a defective Mitraclip® system: Considerations on the medical device regulation in Europe
    Subjects: “...medical device regulation....”
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    Article
  6. 6
    Comprehensive Review on Current and Future Regulatory Requirements on Wearable Sensors in Preclinical and Clinical Testing
    Subjects: “...Medical Device Regulation...”
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    Article
  7. 7
    Tissue engineering and regenerative medicine: Semantic considerations for an evolving paradigm
    by Ravi eKatari, Andrea ePeloso, Giuseppe eOrlando
    Published 2015-01-01
    Subjects: “...device regulation...”
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    Article
  8. 8
    Standardization of in vitro testing for cardiovascular implants in the era of European Medical Device Regulation
    Subjects: “...medical device regulation...”
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    Article
  9. 9
    Standardization of in vitro testing for cardiovascular implants in the era of European Medical Device Regulation
    Subjects: “...medical device regulation...”
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    Article
  10. 10
    Rise of Clinical Studies in the Field of Machine Learning: A Review of Data Registered in ClinicalTrials.gov
    by Claus Zippel, Sabine Bohnet-Joschko
    Published 2021-05-01
    Subjects: “...device regulation...”
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    Article
  11. 11
    Medical Device Regulation Efforts for mHealth Apps during the COVID-19 Pandemic—An Experience Report of Corona Check and Corona Health
    Subjects: “...medical device regulation...”
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    Article
  12. 12
    Effectiveness of Direct Safety Regulations on Manufacturers and Users of Industrial Machines: Its Implications on Industrial Safety Policies in Republic of Korea
    by Gi Heung Choi
    Published 2017-03-01
    Subjects: “...safety device regulation...”
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    Article
  13. 13
    Big data and predictive analytics in healthcare in Bangladesh: regulatory challenges
    Subjects: “...Medical device regulation...”
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    Article
  14. 14
    The Impact of Medical Devices Regulations on Notified Bodies and Additive Manufacturing
    by Qi, Jianing, Wei, Shilun
    Published 2020
    Subjects: “...Medical device regulation...”
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  15. 15
    China's Particle Therapy Equipment Market: Opportunities Outweigh Challenges
    by Zhongying Dai, Yuanyuan Ma, Qiang Li
    Published 2020-12-01
    Subjects: “...medical device regulation (MDR)...”
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    Article
  16. 16
    Registro e tecnovigilância de implantes dentários: panorama atual nos EUA, na União Europeia, no Brasil e sugestões de aprimoramento desses sistemas | Registry and surveillance of dental implants: current panorama in the USA, European Union, Brazil and suggestions for improved systems
    Subjects: “...Dental Implants; Medical Device Regulation; Technovigilance; Post-marketing Surveillance...”
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    Article
  17. 17
    FDA, CE mark or something else?—Thinking fast and slow
    by Sundeep Mishra
    Published 2017-01-01
    Subjects: “...Device regulation...”
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    Article
  18. 18
    Providing clinical evidence under the MDR 2017/745: New challenges for manufacturers in medical device industry
    Subjects: “...medical device regulation 2017/745 (mdr)...”
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    Article
  19. 19
    A Method for the Classification of Digital Health Architectures as Medical Devices; a Digital Health Research Perspective
    Subjects: “...Medical Devices Regulation (MDR)...”
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    Article
  20. 20
    Getting your devices ready for MDR compliance – a clinical approach and orthopaedic device manufacturers’ perspective
    by Peter Fennema, Hassan Achakri
    Published 2019-07-01
    Subjects: “...Medical Devices Regulation...”
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    Article
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