A roadmap to ISO 14971 implementation-Reference-Cited by-同舟云学术

A roadmap to ISO 14971 implementation

Published:2015-04-14 Issue:5 Volume:27 Page:319-336
ISSN:2047-7473
Container-title:Journal of Software: Evolution and Process
language:en
Short-container-title:J. Softw. Evol. and Proc.

Author:

Flood Derek¹,McCaffery Fergal¹,Casey Valentine¹,McKeever Ruth¹,Rust Peter

Affiliation:

1. Dundalk Institute of Technology; Dundalk Ireland

Funder

Science Foundation Ireland

Publisher

Wiley

Subject

Software

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/smr.1711/fullpdf

Reference48 articles.

1. High-confidence medical device software and systems;Lee;Computer,2006

2. Burton J Mc Caffery F Richardson I Improving software risk management in a medical device company Vancouver, Canada 2009 152 162

3. ISO 14971 Medical devices - application of risk management to medical devices Switzerland ISO 2007

4. Food and Drugs Administration (FDA) Infusion pumps improvement initiative 2010 www.fda.gov/medicaldevices/productsandmedicalprocedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm205424.htm

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