The Project
From GxPlex
The Project
GxPlex was started to address the need for a transparent, traceable document management system tailored to medical device regulation.
Background
Regulatory documentation under MDR (EU 2017/745) and IVDR (EU 2017/746) requires structured, versioned, and approved records. GxPlex provides a wiki-based platform optimised for this workflow.
Goals
- Traceable document lifecycle from draft to approved
- Full-text and property-based search across all documents
- Role-based access for authors, reviewers, and administrators
Status
The project is currently in active development.
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