UDI & Submission Ops
Operational tooling for clean datasets, validations, and submission packaging — built to reduce rework.
- Field hygiene + consistency checks
- Calibration/validation checklists
- Submission bundles (ZIP structure + manifest)
Regulatory & Quality RegTech
Audit-grade compliance automation — engineered for evidence.
We help RA/QA teams build repeatable submission ops, UDI workflows, and documentation pipelines that survive audits: deterministic outputs, traceability, and fail-closed checks.
Evidence-first
Designed for audit defense
Deterministic
Same input → same output
Practical
Templates + packs + workflows
General information only. Not legal advice. Controlled disclosure available for sensitive materials.
Core deliverables
UDI Ops
Swissdamed / EUDAMED readiness
Evidence Packs
Audit-ready structures + manifests
QA Automation
Doc control + change control
Reporting
Status dashboards & summaries
We optimize for clarity under pressure: messy data, tight deadlines, zero tolerance for invented facts.
Operating principle
Every claim maps to evidence. Every deliverable has versioning, a change log, and a verification path.
Traceability
Fail-closed
Audit-ready
Solutions
Three tracks. Start with one pack, then scale into a full operating system.
Audit-Grade Evidence Packs
A repeatable structure for “what happened, when, by whom, and why it’s compliant”.
- Versioned deliverables + change logs
- Evidence mapping (claims → sources)
- Stakeholder summaries (HTML/PDF)
Quality Systems Automation
Reduce overhead in document control and change management with standardized workflows.
- SOP templates + controlled revisions
- Impact assessments + approvals trail
- Cross-team handoff packs
Start small
Most teams don’t need a “platform” on day one. Start with a clean evidence pack and one workflow, then iterate.
Proof
Public examples are anonymized and designed to show structure, not proprietary content.
What you get
- Acceptance criteria and sanity checks
- Deterministic templates and validators
- Documentation that survives handoffs
What you won’t get
- Made-up laws, deadlines, or “trust me” compliance
- Vague claims without verification steps
- Careless handling of confidential materials
Example output types
Public-safe (structure-only)
v1.0
Submission Status Report
Single-page summary
Evidence Pack ZIP
Manifest + doc map
UDI Field Validator
Rules + warnings + fix list
Change Control Bundle
Risk + impact + approvals
Contact
Direct
Info
Jobs
Phone
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Message
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