Illustrative case studies
How the workflow handles real-world documentation gaps
These are illustrative case studies built on fictional manufacturers and devices. Each follows the same path: problem, workflow, evidence, gaps, resolution and audit readiness. They show how MDRpilot is used; they are not customer results and make no outcome claims.
Scenarios
- Illustrative case studyOphthalmic Device Technical Documentation: An Illustrative Case StudyIllustrative scenario: a sterile, EO-sterilised ophthalmic device moves from scattered evidence to a traceable MDR technical file, with gaps in biocompatibility, EO residuals, sterilisation, PMS/PMCF and traceability.Read the scenario
- Illustrative case studyMDR Technical File Gap Analysis: An Illustrative Case StudyIllustrative scenario: a legacy MDD Class IIb device file is analysed against MDR Annexes I, II, III and XIV, and the gaps are turned into a tracked plan.Read the scenario
- Illustrative case studyBuilding an ISO 13485 QMS: An Illustrative Case StudyIllustrative scenario: a small manufacturer builds its ISO 13485 QMS from a company profile, a quality manual and a chained set of core procedures, then runs its first internal audit.Read the scenario
See it with your own device
Create an account, add your company and one real device. The Suite demo runs for 3 days and the first procedure opens straight away, not an empty dashboard.