Dialysis, hazards, and medical device software: Then and now

Biomedical Instrumentation and Technology

Volumn 43, Issue 1, 2009, Pages 59-62

  Majchrowski, Barbara ^a  

^a ECRI INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOMEDICAL ENGINEERING; DIALYSIS; EQUIPMENT FAILURE ANALYSIS; EQUIPMENT SAFETY; QUALITY ASSURANCE, HEALTH CARE; RISK MANAGEMENT; SAFETY MANAGEMENT; SOFTWARE; UNITED STATES;

EID: 60849116711     PISSN: 08998205     EISSN: None     Source Type: Journal    
DOI: 10.2345/0899-8205-43.1.59     Document Type: Article

References (8)

1. Cooper JG, Pauley KA. Healthcare software assurance. AMIA Annu Symp Proc. 2006; 2006:166-170.
2. ECRI Institute. Health Devices Alerts [database online]. Accessed November 13, 2008.
3. Fries RC, Bloesch AE. Medical device software development. In: Dyro JF. ed. Clinical Engineering Handbook Burlington, MA: Elsevier Academic Press; 2004:359-365.
4. Safe Medical Devices Act of 2000. H.R.3095 107th Congress (2000) Library of Congress. Accessed November 13, 2008.
5. Lee I, Pappas GJ. Cleaveland R, et al. High-confidence medical device software and systems. Computer. 2006 April; 39(4):33-38.
6. Taft, C. CDRH Software Forensics Lab: Applying Rocket Science to Device Analysis. Medical Devices Today. 2007, October 15. Accessed November 13, 2008.
7. U.S. Foodand Drug Administration. Glossary of Computerized System and Software Development Terminology. Accessed November 13, 2008.
8. U.S. Food and Drug Administration. General Principles of Software Validation; Final Guidance for Industry and FDA Staff. January 11, 2002. Accessed November 13, 2008.