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Software Regulatory focuses on the regulatory aspects of software used in medical devices and in clinical trials.
SDLC, CFR 21 Part 11, FDA Regulatory Consultant, Software Validation, software life cycle Verification and Validation, Change Control, Software required in medical devices, 510(k), 510k, PMA, medical device software development FDA software quality, Blood Establishment Computer Software, firmware, PACS, BECS, software safety classification, software level of concern, EN 62304,ISO 62304
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