BZO diagnostic — regulated system posture assessment
A free Business Zone Optimization (BZO) tool for regulated systems. Answer 5 questions across traceability, design-history readiness, continuous monitoring, human factors, and audit-trail integrity. Get an instant readiness score, risk posture, and a prioritized remediation checklist benchmarked against FDA QMSR, IEC 62304, NIST SP 800-53, and SOC 2 — entirely in your browser, no account, no email required.
Run the diagnostic
Engineering self-assessment diagnostic only. Not formal regulatory counsel, not an FDA QMSR inspection outcome, not an IEC 62304 conformance statement, not a NIST SP 800-53 authorization decision, and not a SOC 2 attestation. Results depend entirely on the accuracy of self-reported inputs.
Runs entirely in your browser. Nothing you answer here is sent to any server. Only anonymous, derived counts (which dimension, what band) are recorded as first-party telemetry.
BZO readiness score
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Prioritized remediation checklist
Every dimension scoring below the maximum, ordered highest-scoring-gap first — rubric v1.0.0.
Continue with an engineer
A scoped review of your BZO score and top exposures, not a sales call.
Export your BZO readiness ledger and review your top exposure with a Regulatory Engineer