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Start from intended purpose
Capture the device, users, environments, software functions, data flows, and market route.
CE / UKCA technical file
Make software, risk, usability, and verification evidence review-ready
Technical-file readiness depends on consistent evidence across intended use, architecture, lifecycle controls, risk management, usability engineering, verification, and post-market obligations.
Connect evidence families
Link lifecycle evidence, architecture, risk controls, usability traces, verification, and supplier context.
Expose readiness blockers
Show missing hooks and partial chains so teams can fix gaps before review packaging.
Where this helps
- Software lifecycle and architecture evidence.
- Risk-control traceability across safety, security, privacy, and usability.
- Verification and validation status tied to requirements and mitigations.
- Exportable readiness views for internal review and advisor discussions.
The goal is one controlled evidence picture that can support CE, UKCA, and internal technical-file preparation.