[图书][B] Medical device regulations: global overview and guiding principles
World Health Organization - 2003 - apps.who.int
The regulation of medical devices is a vast and rapidly evolving field that is often
complicated by legal technicalities. For example, legal terms and their meanings are …
complicated by legal technicalities. For example, legal terms and their meanings are …
Human computer interaction and medical devices
C Acharya, H Thimbleby, P Oladimeji - Proceedings of HCI 2010, 2010 - scienceopen.com
To achieve dependable, usable, and well-engineered interactive devices in healthcare
requires applied Human Computer Interaction (HCI) research and awareness of HCI issues …
requires applied Human Computer Interaction (HCI) research and awareness of HCI issues …
Medical device human factors standards: finding them and what they contain
M Follette Story - Proceedings of the Human Factors and …, 2019 - journals.sagepub.com
An HFES Task Force is considering if, when, which, and how HFES research publications
should require the citation of relevant standards, policies, and practices. To support Task …
should require the citation of relevant standards, policies, and practices. To support Task …
A life cycle approach to medical device cybersecurity
G Stern - Biomedical Instrumentation & Technology, 2018 - array.aami.org
In 2016, the University of Vermont's Technical Services Partnership (TSP) made the decision
to align itself with the cybersecurity recommendations of the Medical Device Innovation …
to align itself with the cybersecurity recommendations of the Medical Device Innovation …
Supply chain, information systems play important role in patient safety
C Miceli - Biomedical Instrumentation & Technology, 2014 - array.aami.org
1. Determine the total cost of ownership (TCO). 2. Engage with internal experts like HTM and
third-party decision support systems/services to vet the options. 3. Make IT review and …
third-party decision support systems/services to vet the options. 3. Make IT review and …
[PDF][PDF] 16 The role of human factors engineering in medical device and medical system errors
J GOSBEE, L LIN - linical Risk Management Enhancing patient …, 2001 - ndl.ethernet.edu.et
Most errors in your hospital cannot be addressed using clinical risk management that
focuses on the traditional concerns of litigation, insurance, and personnel discipline. Even …
focuses on the traditional concerns of litigation, insurance, and personnel discipline. Even …
Product development—Safety and usability of medical devices
C Vincent - Contemporary Ergonomics and Human Factors, 2013 - books.google.com
In the field of medical devices, innovation and safety are key drivers for product suppliers.
Standards provide an essential route for suppliers to demonstrate quality and consistency …
Standards provide an essential route for suppliers to demonstrate quality and consistency …
Reframing product life cycle for medical devices
BA Fiedler, Y David - Managing Medical Devices Within a Regulatory …, 2017 - Elsevier
The medical device product life cycle (PLC) is linked to the regulatory processes in industry
leaders in the United States, European Union and other countries who emulate their …
leaders in the United States, European Union and other countries who emulate their …