CRO & IVDR · Technical Documentation & PMS/PMPF
IVDR Technical Documentation
Technical documentation that connects each device claim to its supporting evidence. We prepare missing documents, revise existing files and resolve inconsistencies across the submission.
When this service helps
For incomplete files, new study results, notified-body questions or planned post-market updates. Work is scoped to the documents that need attention.
Scope of work
Technical file and traceability
Device description, GSPR mapping, risk management, IFU and labelling reviewed against the applicable requirements.
Performance evaluation
PEP and PER, scientific validity, analytical and clinical performance reports, with study protocols and reports where applicable.
Post-market documentation
PMS and PMPF plans and reports, plus the applicable PMS report or PSUR. Updates use the actual post-market data.
What you receive
- Reviewed document set
- Agreed files with a consistent intended purpose, terminology and evidence references.
- Open-issue register
- Missing evidence and decisions remain visible, with a proposed owner and next action.
What to prepare
Current technical file and document list; study data and reports; IFU and label versions; risk file; review comments; PMS and complaint data relevant to the scope.