FDA/IMDRF Draft–Standalone SWClinical Evaluation

OBSOLETE – Final Issued December 8, 2017FDA issued a draft guidance developed as part of the Internation Medical Device Regulators Forum entitled “Software as a Medical Device (SaMD): Clinical Evaluation”. This document focuses on how to demonstrate clinical validatity of software as a medical device. Other guidances from FDA and IMDRF address other software aspects such as software validation, premarket submissions, and risk classification among others.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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