Is this aligned with current FDA cybersecurity expectations?

Yes. EU Cyber Resilience Act (CRA) for Medical Devices is delivered against the FDA's 2026 premarket cybersecurity guidance, ANSI/AAMI SW96, ISO 14971, IEC 62304, and IEC 81001-5-1 - and structured to land cleanly in eSTAR.

How is the engagement priced and how long does it take?

Fixed-fee, scoped after a free 30-minute Discovery Session. Most premarket engagements (penetration testing, threat modeling, SBOM, deficiency response) complete in 4-8 weeks. We typically start within 1-2 weeks of contract signature.

What if the FDA still pushes back after we submit?

We back our work with a no-cost deficiency resolution commitment. If your submission is delayed because of a cybersecurity deficiency in our deliverables, we resolve it at no additional cost until that deficiency is closed. We cannot and do not guarantee clearance itself - that is the FDA's decision.

Go-To-Market Compliance

EU Cyber Resilience Act (CRA) for Medical Devices

End-to-end EU Cyber Resilience Act (Regulation 2024/2847) readiness for medical device manufacturers - essential cybersecurity requirements, vulnerability handling, conformity assessment, and ENISA reporting workflow - aligned with MDR/IVDR and your FDA cybersecurity program so one control set produces evidence for both.

250+ FDA submissions. no cybersecurity-related rejections to date.

Senior team
Fixed-fee
Reviewer-ready
Re-test included

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Free 30-min call
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Senior expert, not a sales rep
Fixed-fee quote in 24 hours
NDA available on request

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Reviewed by Christian Espinosa, MBA, CISSP · Founder & CEO

Last reviewed

What's included

Reviewer-ready deliverables in one engagement

Every eu cyber resilience act (cra) for medical devices engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.

CRA scoping: products with digital elements, important/critical class determination
Annex I Part I essential cybersecurity requirements gap assessment
Annex I Part II vulnerability handling process (24-hour ENISA notification)
Conformity assessment route selection (self-assessment, EU-type, full QA)
MDR/IVDR + CRA dual-track documentation crosswalk
Technical documentation, EU declaration of conformity, and CE-mark file

Also in premarket: Full-Service FDA Premarket CybersecurityFDA Deficiency ResponseFDA-Compliant SBOM Services

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