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Operations Maturity Audit — Medical Devices
Score how mature Medical Devices operations are — and pinpoint the weakest handoff to fix first.
What this audit examines in Medical Devices
- Regulatory affairs modernization — the generative submission tooling, technical file infrastructure, and SaMD/PCCP framework that compresses regulatory cycle time and absorbs the AI/ML device complexity.
- QMS and design control modernization — the QSR/QMSR documentation, CAPA, supplier, and complaint-handling infrastructure that turns the QMS from a paper exercise into a managed digital system.
- AI/ML device and SaMD platform — the device-embedded AI, model lifecycle management, clinical validation, and post-market monitoring infrastructure that lets the company ship AI-enabled devices defensibly.
- Post-market surveillance and vigilance platform — the adverse event triage, signal detection, and MDR reporting infrastructure that turns post-market into a real-time safety capability instead of a paperwork burden.
Data & Reporting
Whether you can see the business clearly and act on it.
More tools for Medical Devices
AI Readiness Audit
Score process clarity, data readiness, team adoption, and guardrails before investing in AI.
Sample output
67/100 → pilot with control, not full rollout
Digital Transformation Audit
Assess KPI clarity, reporting, tool alignment, ownership, and automation maturity.
Sample output
52/100 → foundation gaps in metrics and handoffs
Supplier Cost Audit
Assess supplier diversification, cost visibility, pricing competitiveness, and negotiation strength.
Sample output
65/100 → 3-5% cost reduction opportunity
Cost of Manual Work — Medical Devices
Quantify the annual cost and people-weeks lost to repetitive manual work — and the automation payback.
Build vs Buy — Medical Devices
Compare the multi-year total cost of SaaS subscriptions against a custom build — with a clear build, buy, or hybrid recommendation.
Revenue Leak — Medical Devices
See how much revenue leaks every month from a low conversion rate — and what closing the gap to your target is worth.