This case study illustrates how targeted ISO 13485 support can enable a SaMD and IVD medical device start-up to establish robust, compliant quality systems and achieve audit readiness.
Establishing readiness for clinical trial manufacturing is a multidimensional process requiring attention to regulatory compliance, facility and personnel preparedness, quality systems, process validation, supply chain management, and risk oversight.
How Risk Impacts Medicine Supply in Australia
AI’s Rapidly Growing Role in Predicting Clinical Trial Success