FDA - IDE, HDE, HUD, NDA, 510(k), PMA & Combination products o EU - CE, IVDD, Design Dossier, MDD o Canadian Health Class I-IV, CMDR o Japanese Ministry of Health (MHLW) Computer System Validation for Equipment, Processes and Products o IEEE, ISO/IEC, ISPE (GAMP4), SEI (Security, Software Development, & Auditing)
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