Regulatory requirements that bend to your workflow — not the other way around.
End-to-end cybersecurity compliance — from SBOM to FDA clearance and EU MDR conformity.
Fixed-rate cybersecurity deliverables through FDA clearance and EU MDR/IVDR compliance — covering ISO 81001-5-1 and MDCG 2019-16 submissions — plus one year of post-market support. Every artifact, every review, every submission — covered.
Compressed timeline option for teams with urgent submission deadlines.
Continuous software bill of materials monitoring, vulnerability disclosure coordination, and patch management aligned to IEC 81001-5-1.
Assess your current cybersecurity posture against FDA expectations and ISO/IEC 81001-5-1. Actionable roadmap to close every gap.
Deep expertise across the regulatory landscape that matters.
Built by engineers who've shipped regulated software — not consultants who've only reviewed it.
Guides, analysis, and tools for medical device cybersecurity professionals.
A practical breakdown of the QMSR harmonization with ISO 13485 — what it means for your cybersecurity documentation.
AnalysisStep-by-step guide to building an SPDF that satisfies FDA expectations without derailing your engineering workflow.
ArticleThe non-negotiable cybersecurity requirements every medical device submission needs to address.
Talk to us about your device, your timeline, and your regulatory targets. No sales pitch — just a straightforward assessment of what you need.
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