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
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
EU Cyber Resilience Act (CRA) for Medical Devices FAQs
EU CRA readiness for connected 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.