What a cyber deficiency really costs you.
One FDA cybersecurity deficiency typically delays clearance 4–12 weeks. Plug in your numbers to see the real impact on revenue and gross profit.
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Best estimate - assumes full launch. Type any whole-dollar amount.
Typical cyber deficiency: 4–12 weeks.
Re-submission cost assumes ~$15K/week of internal + external rework, in line with median MedTech projects we've seen.
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We'll send the 7 most common FDA cyber deficiencies and how to prevent each - plus your full ROI model in PDF.
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The fastest way to compress your timeline is to fix the deficiency before it happens. Start with the playbook, the readiness check, or the FDA premarket package.
FDA premarket cybersecurity services
End-to-end SPDF, SBOM, threat model, and pen test - delivered in time for your submission window.
Learn moreFDA deficiency response
Already received a hold or AI letter? We close cybersecurity deficiencies on the first resubmission.
Learn moreReadiness self-assessment
5-minute quiz that scores your submission readiness and surfaces the 3 fastest wins.
Learn moreThreat modeling
AAMI SW96 / ISO 14971-aligned threat models reviewers expect to see.
Learn moreFDA-compliant SBOMs
SPDX/CycloneDX SBOMs with CVE mapping and end-of-life tracking.
Learn moreCybersecurity FAQ
Straight answers on FDA Section 524B, SBOMs, pen testing, and timelines.
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