Analysis of a “simple” medical device

WA Rogers, AL Mykityshyn… - Ergonomics in …, 2001 - journals.sagepub.com
… included with the test strips, and instructions for a lancing device, which holds the lancet (ie,
sterile needle) used to prick the finger to obtain a drop of blood for testing. The meter also …

[图书][B] Usability testing of medical devices

ME Wiklund, J Kendler, AY Strochlic - 2015 - books.google.com
test to demonstrate that their medical devices are safe to use from an interaction design
standpoint. During either type of test, users’ interactions with the given medical device … , testing

Medical device development: from prototype to regulatory approval

AV Kaplan, DS Baim, JJ Smith, DA Feigal, M Simons… - Circulation, 2004 - Am Heart Assoc
medical device companies typically develop successive iterations of existing devices, most
new device … Clinical testing of an unapproved significant-risk medical device requires FDA …

Study of the in vitro cytotoxicity testing of medical devices

W Li, J Zhou, Y Xu - Biomedical reports, 2015 - spandidos-publications.com
… is suitable for detecting the toxicity of soluble substances of medical devices and is usually
… most sensitive for testing the cytotoxicity of the medical devices; the medical devices can be …

Medical devices on chips

A Guan, P Hamilton, Y Wang, M Gorbet, Z Li… - Nature Biomedical …, 2017 - nature.com
… , yet there has been little recognition or support for the use of this technology in the
development and testing of medical devices. In this Perspective, we introduce the concept of …

From in vivo to in vitro: The medical device testing paradigm shift

DK Myers, AM Goldberg, A Poth, MF Wolf… - ALTEX-Alternatives to …, 2017 - altex.org
testing of medical devices can be more effective, both in terms of cost and time, and also more
reliable than in vivo testing. … , regulatory acceptance of alternative testing methods has not …

[图书][B] Design and development of medical electronic instrumentation: a practical perspective of the design, construction, and test of medical devices

D Prutchi, M Norris - 2005 - books.google.com
… the design of medical device proto… testing, and basic high-potential tester. In Chapter 4 we
discuss international regulations regarding electromagnetic compatibility and medical devices

[PDF][PDF] Medical devices: The therac-25

N Leveson - Appendix of: Safeware: System Safety and …, 1995 - cs.colostate.edu
… These accidents have been described as the worst in the 35-year history of medical … material
obtained from the US Food and Drug Administration (FDA), which regulates these devices. …

Barriers to medical device innovation

J Bergsland, OJ Elle, E Fosse - Medical Devices: Evidence and …, 2014 - Taylor & Francis
… of medical devices were introduced without much testing, either technical or clinical, the
process of introducing a Class III medical device … clinical testing. The modern era of implantable …

Medical device regulations and testing for toxicologic pathologists

JACL Schuh - Toxicologic Pathology, 2008 - journals.sagepub.com
… working on harmonizing the categorization and testing of medical devices. The International
testing programs for biomaterials and medical devices. With growth of the medical device