FDA 483 - Smaart Medical Systems, Inc - May 09, 2025

Smaart Medical Systems, Inc. in Dallas, TX, a manufacturer of Class II medical device software (eVolve PACS), was cited for numerous significant quality system deficiencies during an FDA inspection. The firm failed to establish or implement critical procedures for design control, design validation, software validation, MDR, CAPA, complaint handling, management review, quality audits, purchasing, training, acceptance activities, labeling, and document controls. These widespread issues indicate a severe lack of a foundational quality system for a medical device manufacturer.