DQE

Roles & Responsibilities Provide quality oversight for SaMD product development, design controls, software lifecycle activities, verification/validation, release, and design transfer. Review and maintain traceability between user needs, requirements, risk controls, test cases, and results. Support Design History File (DHF) and technical documentation to ensure audit readiness. Facilitate ISO 14971 risk management activities, including hazard analysis, risk evaluation, control implementation, re…