Regulatory Knowledge & AdvisoryContact EUEG OÜControlled work starts with a clear structure
Move from regulatory complexity to traceable work.
Cervion provides editable starting points for medical-device quality, clinical evidence and EU regulatory documentation—built for adaptation, qualified review and organizational control.
Documentation aids only. Cervion does not provide certification, regulatory approval or completed evidence.
Free practical sample
Try a focused document register.
Download an editable XLSX with a blank five-row register, status dropdowns and three clearly fictional worked examples. No signup is required.
Limited administrative aid only. Internal-use adaptation is permitted; resale and redistribution are not. Review suitability and complete your own approval before operational use.
Choose your path
Start with the outcome you need.
Browse a focused pathway or search the complete catalogue by task, evidence type or product code.
QMS operations
Put complaints, CAPA, change control, audits and supplier work into controlled, reviewable structures.
View relevant kitsClinical evidence
Connect planning, literature work, appraisal, synthesis, CER preparation and post-market follow-up.
View relevant kitsTechnical documentation
Organize technical files, GSPR evidence, classification, labelling, UDI and release readiness.
View relevant kitsDetailed starting points
Three high-value workflows.
See the intended outcome, working sequence and professional-use boundary before choosing a kit.
Complaint Handling
Controlled intake, triage, investigation, escalation and closure.
View details CRV-CEE-07CER Preparation and Review
Report structure, source mapping, evaluator controls and maintenance records.
View details CRV-TDR-02GSPR Evidence Matrix
Applicability, conformity methods, evidence locations and gap control.
View detailsFrom evidence to controlled output
A practical operating model—not a claim of automated compliance.
Cervion workflow designs connect evidence, defined tasks, qualified human review and controlled outputs. The current workflow implementation is a reference and design-validation asset; it is not presented as a production SaaS service.
Understand the boundaries- Evidence remains attributable and reviewable
- Human approval stays explicit
- Outputs remain under organizational control
Need help choosing?
Tell us the outcome you are working toward.
Ask about a kit, licence or separately scoped advisory support.