WriteCortex AI™
Think Regulatory. Write Intelligently. Controlled regulatory document authoring: defined document structures, evidence-linked draft generation, source traceability and built-in review steps.
Regulatory documents are long, structured and evidence-heavy. Drafting from scratch is slow, and copied text drifts away from its sources.
- Approved templates and document structures
- Test reports, literature, risk files and PMS data
- Product information and claims
- Applicable requirements and guidance
- Technical documentation sections
- CEP and CER, PEP and PER, SVR
- Risk management files
- PMS plans, PMSR and PSUR
From template to approved document
- 01Select structureDocument type and approved template chosen.
- 02Link evidenceSource documents connected to each section.
- 03DraftEvidence-linked first draft generated, each statement referenced.
- 04ReviewAuthor and reviewer edit, comment and resolve.
- 05Approve and releaseFinal approval and release under your document control.
Drafts are reviewed and approved by a qualified author and reviewer. Release happens in your QMS, not in the tool.
Illustrative draft · fictitious data
Analytical sensitivity. The limit of detection was determined as 0.8 IU/mL from 60 replicates across three reagent lots R2. This supports the claimed limit of detection of 1.0 IU/mL stated in the instructions for use R5. No interference was observed from haemoglobin up to 2 g/L R3.
- R2 APR-014 Limit of detection study report, §5.2
- R3 APR-015 Interference study, Table 4
- R5 IFU version 3, §8
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.