Generating evidence for new high-risk medical devices

被引：7

作者：

Campbell, Bruce ^{[1
]}

Wilkinson, John ^{[2
]}

Marlow, Mirella ^{[3
]}

Sheldon, Murray ^{[4
]}

机构：

[1] Univ Exeter, Med Sch, Exeter, Devon, England

[2] Med & Healthcare Prod Regulatory Agcy MHRA, London, England

[3] Natl Inst Hlth & Care Excellence NICE, London, England

[4] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD USA

来源：

BMJ SURGERY INTERVENTIONS & HEALTH TECHNOLOGIES | 2019年 / 1卷 / 01期

关键词：

technology; HEALTH TECHNOLOGY-ASSESSMENT; CHALLENGES; QUALITY;

D O I：

10.1136/bmjsit-2019-000022

中图分类号：

R61 [外科手术学];

学科分类号：

摘要：

[No abstract available]

引用

页数：5

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[4]

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[5]

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[8]

[Anonymous], 2017, Regulation. (EU), P746

[9]

[Anonymous], 2017, Methodologic Principles in the Use of International Device Registry Data-IMDRF/RegistryWG/N42FINAL

[10] Methodological choices for the clinical development of medical devices [J].

Bernard, Alain ;

Vaneau, Michel ;

Fournel, Isabelle ;

Galmiche, Hubert ;

Nony, Patrice ;

Dubernard, Jean Michel .

MEDICAL DEVICES-EVIDENCE AND RESEARCH, 2014, 7 :325-334

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