An evidence-based risk-oriented V-model methodology to develop ambient intelligent medical software-Reference-Cited by-同舟云学术

An evidence-based risk-oriented V-model methodology to develop ambient intelligent medical software

Published:2017-05-10 Issue:1 Volume:3 Page:41-53
ISSN:2199-4668
Container-title:Journal of Reliable Intelligent Environments
language:en
Short-container-title:J Reliable Intell Environ

Author:

Cicotti Giuseppe^ORCID

Publisher

Springer Science and Business Media LLC

Subject

Renewable Energy, Sustainability and the Environment,Artificial Intelligence,Computer Science Applications,Computer Networks and Communications

Link

http://link.springer.com/article/10.1007/s40860-017-0039-9/fulltext.html

Reference29 articles.

1. Directive, Council (1993) 93/42/EEC of 14 June 1993 concerning medical devices, pp 1–46. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri= CONSLEG:1993L0042:20071011:en:PDF

2. FDA (2007) Title 21 Food and Drugs Chapter I Food and Drug Administration Department of Health and Human Services Subchapter H Medical Devices Part 820 Quality System Regulation. U.S. Department of Health and Human Services. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=820 . Accessed Sept 2016

3. ISO 13485 (2003) Medical devices-quality management systems-requirements for regulatory purposes. International Organization for Standardization, Geneva

4. Association for the Advancement of Medical Instrumentation (2007) Medical devices: application of risk management to medical devices. Association for the Advancement of Medical Instrumentation

5. International Electrotechnical Commission (2006) Medical device software: software life cycle processes. IEC

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