FDA 483 - S.M.A.I.O - September 19, 2024

An FDA inspection of S.M.A.I.O in Saint-Priest identified significant deficiencies in the firm's design and development activities for its medical device software. The company's software development procedure and product requirements document contained ambiguous, incomplete, or non-measurable design inputs, and a distributed Class II medical device software, "KEOPS Balance Analyzer 3D, version 2.2", was found to lack a completed risk analysis. These issues indicate a failure to adequately establish design plans, potentially impacting the safety and effectiveness of the device.