Fusion provides comprehensive engineering, quality, and regulatory support to medical device and life sciences companies that operate in highly controlled environments. Our teams help clients manage end-to-end product development cycles, from early concept design to commercial manufacturing. We deploy professionals with deep expertise in validation, sterilization, environmental monitoring, and quality engineering to ensure every process aligns with FDA, ISO 13485, GMP, and 21 CFR Part 11 requirements. Fusion’s specialists assist with risk management, device history records, equipment qualification, and software validation, enabling compliant and efficient production systems. Whether supporting Class I–III medical devices, diagnostic instruments, or laboratory systems, Fusion strengthens operational readiness and ensures products meet the strictest global quality and safety standards.