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. Zero rejections.
- Senior team
- Fixed-fee
- Reviewer-ready
- Re-test included
- Free 30-min call
- No obligation
- Senior expert, not a sales rep
- Fixed-fee quote in 24 hours
- NDA available on request
Trusted by leading MedTech companies
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
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Learn moreEU Cyber Resilience Act (CRA) for Medical Devices FAQs
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"Blue Goat Cyber's depth of expertise was impressive. We had no in-house cybersecurity experience, and their team guided us through every step of the FDA process. The penetration testing and SBOM testing were thorough and gave us complete confidence."
EU Cyber Resilience Act (CRA) for Medical Devices - scoped, fixed-fee, FDA-ready.
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.