A requirement-by-requirement review of your quality system.
Join the early access list
We’re building a requirement-by-requirement review of your quality system. Leave your email and we’ll let you know the moment it’s ready.
Standards we review
QMSR / ISO 13485
48 requirements across design controls, CAPA, document control, management responsibility, and more.
ISO 14971 — Risk Management
9 requirements covering risk process, hazard identification, risk controls, and residual risk evaluation.
IEC 62304 — Software Lifecycle
26 requirements for safety classification, architecture, testing, SOUP management, and maintenance.
IEC 62366 — Usability Engineering
14 requirements for usability process, use specification, formative evaluation, and summative testing.
IEC 81001-5-1 — Cybersecurity Lifecycle
46 requirements for secure development, threat modeling, SBOM, vulnerability management, and post-market security.
FDA Cybersecurity
23 requirements including premarket cyber device scoping, SBOM, penetration testing, and coordinated vulnerability disclosure.
FDA Postmarket Surveillance (21 CFR)
18 requirements for MDR adverse-event reporting, corrections and removals, and postmarket surveillance plans.
...and more standards coming soon.
Free compliance review. Pay only for the detailed report.
No credit card. No sales call. No consultants required.
We'll notify you when the scanner launches. No spam.