483
Excel Medical Electronics LLCExcel Medical Electronics LLC – FDA 483, Dec 19, 2025
Record Details
Excel Medical Electronics LLC, a manufacturer of medical electronics, was inspected and cited for deficiencies in its quality system. The inspection revealed inadequate procedures for design verification, specifically regarding the Wave Clinical Platform Software, and an insufficient risk analysis that failed to include pertinent risks and mitigation actions related to software configuration. These issues indicate a need for improved quality system controls.
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ID · 74e30dd9-54c4-41d2-8a48-48e4fc7f0920
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