Tool Sprawl Risk Audit — Medical Devices

Signs of tool sprawl in Medical Devices

• 510(k), De Novo, and PMA cycles are the gating constraint on revenue — every quarter of clearance delay slips revenue, the regulatory affairs team is small relative to the pipeline, and the FDA's review timelines have meaningful variance.
• FDA QSR / 21 CFR Part 820 (transitioning to QMSR / ISO 13485 alignment) is a continuous compliance burden — every design control, every CAPA, every supplier qualification, every complaint must be documented and audit-ready.
• AI/ML-enabled devices add a new regulatory complexity — Software as a Medical Device (SaMD), the Predetermined Change Control Plan (PCCP), and the FDA's evolving AI/ML guidance require model documentation and post-market monitoring infrastructure most legacy device companies don't have.
• Post-market surveillance is heavy and growing — adverse event reporting, MDR/MAUDE submissions, complaint handling, EU MDR vigilance reporting, and post-market clinical follow-up consume significant operations capacity.