Services

Cyber Submissions Package

Complete cybersecurity documentation for FDA clearance and EU MDR/IVDR compliance. Fixed price, clear scope, engineering-first delivery.

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Full Submissions Package

We produce the complete cybersecurity documentation package for your submission.

  • All required cybersecurity documentation for either FDA or EU submission
  • Assistance with eSTAR or Notified Body submission
  • Assistance responding to FDA feedback
  • Full trace analysis to packages
  • 1 year post-market support
  • Need it yesterday? FastTrack option available
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Documentation Review & Remediation

Already have cybersecurity documentation? We'll review what you have against current regulatory expectations and fix what needs fixing.

  • Full traceability analysis against FDA Premarket Guidance, ISO 81001-5-1, MDCG 2019-16
  • Critical review of current FDA "hot button" issues
  • Analysis informed by reviewer feedback from other submissions
  • Prioritized findings report with criticality ratings
  • Optional remediation — we fix the gaps, not just find them
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What we need from you

We keep client inputs minimal and focused.

  • Device description and intended use
    Software architecture overview
    Current SBOM (if available)
    Regulatory targets (FDA, EU, both)
    Timeline constraints

What you get

Submission-ready artifacts, not slide decks.

  • Complete cybersecurity submission file
    Threat model documentation
    SBOM with vulnerability analysis
    Post-market surveillance plan
    Ongoing support for 12 months
Timeline

Standard vs. FastTrack

Choose the timeline that fits your submission schedule.

Standard

Week 1-2

Kickoff, architecture review, scope finalization

Week 3-6

Threat modeling, SBOM analysis, documentation drafting

Week 7-8

Review cycles, finalization, delivery

Ongoing

12-month post-market support

FastTrack

Week 1

Accelerated kickoff and parallel workstreams

Week 2-3

Concurrent threat modeling, SBOM, and documentation

Week 4

Rapid review and delivery

Ongoing

12-month post-market support

FAQ

Common questions

We scope your project upfront and provide a fixed price for the complete deliverable. No hourly billing, no scope creep surprises. If we underestimate, that's on us — not you.
We'll review what you have during the assessment phase. If existing artifacts are usable, we'll build on them rather than starting from scratch. This often reduces scope and cost. We also offer a standalone Documentation Review & Remediation service for teams that already have a package but want it checked and improved.
Yes. Our Cyber Submissions Package covers both FDA premarket cybersecurity requirements and EU MDR/IVDR expectations, including alignment to ISO 81001-5-1 and MDCG 2019-16.
Twelve months of vulnerability monitoring for your SBOM components, coordinated disclosure support, and guidance on regulatory updates that affect your submission.
FastTrack delivers in approximately 4 weeks compared to the standard 8-week timeline. This is achieved through parallel workstreams and accelerated review cycles, not by cutting corners.

Ready to get started?

Tell us about your device and timeline. We'll provide a clear scope and fixed price within a few days.

Get in touch contact@regusoft.com