1. FDA. FDA News on Software Failures Responsible for 24% of all Medical Device Recalls (2012),
http://www.fdanews.com/newsletter/article?articleId=147391&issueId=15890
(cited April 12, 2013)
2. European Commission, Directive 93/42/EEC of the European Parliament and of the Council concerning medical devices, in OJ o L 247 of 2007-09-21. 1993: European Commission, Brussels, Belgium
3. FDA. Chapter I - Food and drug administration, department of health and human services subchapter H - Medical devices, Part 820 - Quality system regulation,
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820
(cited May 15, 2013)
4. European Commission, Council directive 90/385/EEC on active implantable medical devices (AIMDD). 1990: Brussels, Belgium
5. European Commission, Directive 98/79/EC of the European parliament and of the council of 27 October 1998 on in vitro diagnostic medical devices. 1998: Brussels, Belgium