1. FDA: Chapter I - Food and drug administration, department of health and human services subchapter H - Medical devices, Part 820 - Quality system regulation, May 2015.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820
2. Directive 93/42/EEC of the European Parliament and of the Council concerning medical devices (1993)
3. Council directive 90/385/EEC on active implantable medical devices (AIMDD) (1990)
4. Directive 98/79/EC of the European parliament and of the council of 27 October 1998 on in vitro diagnostic medical devices (1998)
5. Directive 2007/47/EC of the European Parliament and of the Council concerning medical devices (2007)