One workflow, applied where regulated data drifts.
Each page below applies the same workflow — approved source, expected surfaces, deterministic comparison, reviewer queue, closure evidence — to one regulatory object or situation. Every one of them is delivered as a Portfolio Integrity Scan or a Regulatory Change Integrity Review.
EUDAMED & UDI data
Registered device and actor records against controlled sources: field-level reconciliation, identifier structure, transition registration workload.
SS(C)P operations
Master, revision, translation and publication state held consistent with the technical documentation and the public record.
Class III / implantable MDR transition
Portfolio mapping, timing, evidence gaps and accountable review for the highest-stakes transition workload.
Authorised-representative portfolios
For ARs and consultancies managing many manufacturers: triage records, find missing evidence, hand over portable evidence packets.
Controlled document consistency
The same fact held consistent across DoC, label, IFU, technical file summary and registration data — and change propagation between them.
Language-version integrity & Danish linguistic validation
The approved fact held consistent across every maintained language version of labels, IFUs and SS(C)P translations, with medically literate Danish↔English review where it is needed.
Denmark market access & Danish PV
Danish authority mapping, market-specific evidence, controlled localisation and Danish pharmacovigilance support.
Regulatory change impact
When a regulation or guidance changes: which document and data surfaces are touched, in what order, with what evidence to capture.
Specimens on fictional data
Inspect the working method before bringing your own data: a specimen register and a portfolio work-plan sample.