FDA 483 - Seniorlife Technologies Inc - March 26, 2025

An FDA inspection of Seniorlife Technologies Inc. in Bellevue, WA, a manufacturer of a Class II Software as a Medical Device (SaMD), revealed significant deficiencies across its quality system. The firm lacked established written procedures for critical areas including Medical Device Reporting, design control, corrective and preventive actions, complaint handling, training, and quality audits. Additionally, no management representative had been appointed to oversee the quality system, indicating a fundamental absence of essential quality management processes.