A threat model, SBOM, and CVE monitoring plan, ready to drop into your FDA or MDR technical file.
A documentation gap check against IEC 62304 and IEC 81001-5-1, with a live review session before your next audit.
Pre-built Design & Development File templates aligned to QMSR and IEC 62304, so your team starts sprint one compliant.
An architecture blueprint and working Sprint 0 connection to EU EHR systems, built on HL7 FHIR and GDPR Article 9.
A senior CTO on retainer, two days a week, covering roadmap, hiring, and architecture decisions as you scale.
A hands-on codebase and documentation review across five workstreams, built for investors and acquirers doing due diligence.
