作者：Comeron W. Ghobadi ; MD^a ; ^{comeron.ghobadi@uchospitals.edu} ; Emily L. Hayman ; MD^b ; Joshua H. Finkle ; MD^a ; Jessica R. Walter ; MD^c ; Shuai Xu ; MD ; MSc(Lond)^d

关键词：Medical device innovation ; FDA ; patient safety ; health policy ; medical device regulation ; innovation ; 21st Century Cures Act ; National Evaluation System for Health Technology

刊名：Journal of the American College of Radiology

出版年：2017

作者：Ariel Dora Stern ^{astern@hbs.edu}

关键词：Regulation ; Innovation ; FDA ; Medical devices

刊名：Journal of Public Economics

出版年：2017

作者：Bodil Ivarsson^a ; ^b ; ^{bodil.ivarsson@med.lu.se" class="auth_mail" title="E-mail the corresponding author} ; Stig Wiinberg^b ; Martin Svensson^b

关键词：Healthcare technology ; Healthcare information security ; Knowledge ; Patient safety ; Regulation ; Staff attitudes

刊名：Health Policy and Technology

出版年：2016

作者：Comeron W. Ghobadi ; MD^a ; ^{Comeron.Ghobadi@uchospitals.edu" class="auth_mail" title="E-mail the corresponding author} ; Emily L. Hayman ; MD^b ; Shuai Xu ; MD ; MSc^c

关键词：Medical device recall ; FDA ; health policy ; patient safety ; 21st Century Cures Act ; medical device regulation

刊名：Journal of the American College of Radiology

出版年：2016

作者：David R. Holmes Jr. ; MD^a ; ^{holmes.david@mayo.edu" class="auth_mail" title="E-mail the corresponding author} ; Robert Califf ; MD^b ; Andrew Farb ; MD^b ; Dorothy Abel ; BSBME^b ; Michael Mack ; MD^c ; Tamara Syrek Jensen ; JD^d ; Bram Zuckerman ; MD^b ; Martin Leon ; MD^e ; Jeff Shuren ; MD^b

关键词：equipment design ; new device development strategies ; research design ; research ethics committees ; United States Food and Drug Administration

刊名：Journal of the American College of Cardiology

出版年：2016

作者：Nurus Sakinatul Fikriah ; ^{nuruzshith@yahoo.com" class="auth_mail" title="E-mail the corresponding author} ; Hartini Saripan ; Dr. ; Zulhabri Ismail ; Dr.

关键词：medical robotic ; medical device regulation ; law and technology

刊名：Procedia Computer Science

出版年：2015

作者：P. Tracol ; ^{phtracol@orange.fr" class="auth_mail" title="E-mail the corresponding author}

关键词：Materials vigilance ; Traceability ; Medical devices ; Unique device identifier ; CE marking

刊名：Orthopaedics & Traumatology: Surgery & Research

出版年：2016

作者：Raffick A.R. Bowen^a ; ^{rbowen@stanfordhealthcare.org} ; Dorothy M. Adcock^b

关键词：Blood ; Collection ; Preanalytical ; Tube ; Validation ; Verification

刊名：Clinical Biochemistry

出版年：2016

作者：Shawn H.E. Harmon^a ; ^b ; ^c ; ^{shawn.harmon@ed.ac.uk" class="auth_mail" title="E-mail the corresponding author}Author Vitae ; Dinar Kale^d ; ^e ; ^{dinar.kale@open.ac.uk" class="auth_mail" title="E-mail the corresponding author}Author Vitae

关键词：Regulation ; Governance ; Innovation ; Principles ; Regenerative medicine ; Medical devices ; Argentina ; India

刊名：Technology in Society

出版年：2015

作者：Leigh Anderson¹ ; Patrick Antkowiak¹ ; Aden Asefa¹ ; Amber Ballard¹ ; Tushar Bansal¹ ; Ayo Bello¹ ; Bernard Berne¹ ; Kristen Bowsher¹ ; Bennett Blumenkopf¹ ; Ian Broverman¹ ; Mohamad Bydon¹ ; Kuo Chao¹ ; Peter Como¹ ; Karlene Cork¹ ; Ann Costello¹ ; Kathryn De Laurentis¹ ; Angela DeMarco¹ ; Heather Dean¹ ; John Doucet¹ ; Bradley Dworak¹ ; Lisa Epperson¹ ; Eric Franca¹ ; Naz Ghassemian¹ ; Chandramallika Ghosh¹ ; Anupama Govindarajan¹ ; Jay Gupta¹ ; Stacie Gutowski¹ ; Robert Herrmann¹ ; Michael Hoffmann¹ ; William Heetderks¹ ; Steven Hsu¹ ; Daryl Kaufman¹ ; Erin Keegan¹ ; Gregg Kittlesen¹ ; Kevin Khuu¹ ; Hyung Lee¹ ; Larry Lo¹ ; Ian Marcus¹ ; Timothy Marjenin¹ ; Binoy Mathews¹ ; Sanjay Misra¹ ; Vivek Pinto¹ ; Vesper Ramos¹ ; Samuel Raben¹ ; Avena Russell¹ ; Devjani Saha¹ ; Joonil Seog¹ ; Christian Shenouda¹ ; Myra Smith¹ ; Xiaorui Tang¹

刊名：Neuron

出版年：2016