Tool Sprawl Risk Audit — Medical Devices

Find out how much spreadsheet and SaaS sprawl is costing Medical Devices — and where a purpose-built internal tool pays off.

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.

Section 1 of 4 · Source of Truth0/8 answered

Source of Truth

Whether your operational data lives in one place or is scattered across tools.

1.Where does your core operational data live?

2.How many tools/spreadsheets hold 'the truth' for one workflow?

Send us the result and the constraint behind it. We’ll scope the diagnostic, sprint, or build that fixes what the score reveals.