1. IEC IEC TR 80002-3 : Medical device software -- Part 3 : Process reference model of medical device software life cycle processes ( IEC 62304 ) 2014
2. 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
3. European Commission Directive 93/42/EEC of the European Parliament and of the Council concerning medical devices OJ o L 247 of 2007-09-21 1993
4. European Commission Council directive 90/385/EEC on active implantable medical devices (AIMDD) 1990