A requirement-by-requirement scan of your quality system.
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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.
A free compliance scan is coming.
No credit card. No sales call. No consultants required.
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