The international standard<unk>  – medical device software – software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices. It is harmonized by the European Union (EU) and the United States (US), and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.
IEC 62304
EPI-001
Hs and Ts
OM-85
SM-102
Toca 511 and Toca FC
EMMS International
QuikClot