How the new European regulation on medical devices will affect innovation

被引：0

作者：

Shiko M. Ben-Menahem

Raymond Nistor-Gallo

Gloria Macia

Georg von Krogh

Jörg Goldhahn

机构：

[1] ETH Zürich,Department of Management, Technology and Economics

[2] QMD Services GmbH,Department of Health Sciences and Technology

[3] F. Hoffmann-La Roche AG,undefined

[4] ETH Zürich,undefined

来源：

Nature Biomedical Engineering | 2020年 / 4卷

关键词：

D O I：

暂无

中图分类号：

学科分类号：

摘要：

The European Union’s new regulatory framework for medical devices has central implications for the development of new devices, particularly by start-ups.

引用

页码：585 / 590

页数：5

共 50 条

[1] How the new European regulation on medical devices will affect innovation
Ben-Menahem, Shiko M.
Nistor-Gallo, Raymond
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von Krogh, Georg
Goldhahn, Joerg
[J]. NATURE BIOMEDICAL ENGINEERING, 2020, 4 (06) : 585 - 590
[2] New European Regulation for Medical Devices
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[J]. EUROPEAN HEART JOURNAL, 2021, 42 (10) : 960 - 961
[3] In vitro medical devices: how businesses can successfully comply with the new European regulation
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Rabin, Norm
[J]. ANNALES DE BIOLOGIE CLINIQUE, 2018, 76 (06) : 716 - 718
[4] New European Regulation for Medical Devices: What Is Changing?
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[J]. CardioVascular and Interventional Radiology, 2019, 42 : 1272 - 1278
[5] New European Regulation for Medical Devices: What Is Changing?
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[J]. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 2019, 42 (09) : 1272 - 1278
[6] Medical Devices - Balancing Regulation and Innovation
Curfman, Gregory D.
Redberg, Rita F.
[J]. NEW ENGLAND JOURNAL OF MEDICINE, 2011, 365 (11): : 975 - 977
[7] Preparing healthcare, academic institutions, and notified bodies for their involvement in the innovation of medical devices under the new European regulation
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Bonin, Mauro
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[8] Regulation of medical devices in the European Union
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[J]. JOURNAL OF LEGAL MEDICINE, 2000, 21 (04) : 537 - 556
[9] REGULATION OF MEDICAL DEVICES IN THE EUROPEAN COMMUNITY
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[J]. FOOD AND DRUG LAW JOURNAL, 1992, 47 (05): : 563 - 570
[10] The New European Medical Device Regulation: Balancing Innovation and Patient Safety
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Gerke, Sara
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Ahmad, Omer F.
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