FDA's self-service medical device ...regulation primer
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm
Advanced Medical Technology Association (AdvaMed, formerly HIMA) (trade group reports on regulatory developments affecting the medical device industry)
http://www.advamed.org
European CE (Conformité Européne) Mark (what the CE Mark is, how to use it, the directives, contacts, etc.)
http://thequalityportal.com/q_cemark.htm
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Medical Device Directive)
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:EN:HTML
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