ISO 13485 Medical Device Regulatory Compliance Support

This opportunity seeks specialized support services to achieve and maintain ISO 13485 certification for medical devices, with particular focus on higher-risk software and AI-based medical devices, including the Probabilistic AI Triage product. The service provider will help ensure regulatory compliance, support quality management system maturity, and provide continuity of expertise in regulatory, quality, and medical device activities. Key deliverables include guidance on certification requirements, documentation support, quality system development, and organizational knowledge retention to prevent delays in product development and deployment timelines.