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Articles (18)

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1-10 of 18 results for medical device regulation (MDR)

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Select article: The Medical Device Regulation of the European Union Intensifies Focus on Clinical Benefits of Devices

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Review article

First published 2019

The Medical Device Regulation of the European Union Intensifies Focus on Clinical Benefits of Devices

Beata Wilkinson, Robert van Boxtel

Therapeutic Innovation & Regulatory Science

Select article: Medical Device Regulations and custom-made device documentation: Ten frequently asked questions and their answers

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Research article

First published 2022-6

Medical Device Regulations and custom-made device documentation: Ten frequently asked questions and their answers

James I.J. Green

Primary Dental Journal

Select article: Medical Device Regulations and custom-made device documentation: A further ten frequently asked questions and their answers

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Research article

First published 2023-3

Medical Device Regulations and custom-made device documentation: A further ten frequently asked questions and their answers

James I. J. Green

Primary Dental Journal

Select article: Medical Device Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices

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Research article

First published 2021-3

Medical Device Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices

James I. J. Green

Primary Dental Journal

Select article: 2023 International Academy of Toxicologic Pathology (IATP) Satellite Symposium: “Medical Device Safety Assessment: Pathology and Toxicology Perspective”

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Meeting report

First published 2025-6

2023 International Academy of Toxicologic Pathology (IATP) Satellite Symposium: “Medical Device Safety Assessment: Pathology and Toxicology Perspective”

Flora Wegener, Antoine Alves, Uta Bussmeyer [...]

Toxicologic Pathology

Select article: Navigating through regulatory frameworks for digital therapeutics and biomarkers

Open access

Review article

First published 2025-10

Navigating through regulatory frameworks for digital therapeutics and biomarkers

Cinja Koller, Marc Blanchard, Thomas Hügle

Health Informatics Journal

Select article: Privacy Concerns Related to Data Sharing for European Diabetes Devices

Open access

Research article

First published 2025-5

Privacy Concerns Related to Data Sharing for European Diabetes Devices

Pietro Randine, Matthias Pocs, John Graham Cooper [...]

Journal of Diabetes Science and Technology

Select article: A novel method for conformity assessment testing of defibrillators for post-market surveillance purposes

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Other

First published 2023-1

A novel method for conformity assessment testing of defibrillators for post-market surveillance purposes

Almir Badnjevic, Amar Deumic, Elma Imamovic [...]

Technology and Health Care

Select article: A novel method for conformity assessment testing of electrocardiographs for post-market surveillance purposes

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Other

First published 2023-1

A novel method for conformity assessment testing of electrocardiographs for post-market surveillance purposes

Almir Badnjevic, Ratko Magjarevic, Emina Mrdjanovic [...]

Technology and Health Care

Select article: A novel method for conformity assessment testing of anaesthesia machines for post-market surveillance purposes

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Other

First published 2023-1

A novel method for conformity assessment testing of anaesthesia machines for post-market surveillance purposes

Almir Badnjevic, Amar Deumic, Zijad Dzemic [...]

Technology and Health Care

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