In-house QMS Platform

An in-house system supporting our AR and document-management work. It keeps your technical documentation and communication transparent and traceable.

Document management

Version control, retention periods and access records for technical documentation, managed in one system.

The mapping between regulatory requirements and internal procedures and records is kept traceable.

Operated in Japanese and English, minimising misunderstandings with Japanese manufacturers.

A secure document-sharing environment, isolated per client.

The platform is under active development; features are being expanded step by step.

We help you map your current position: device class, CE status, and EU clinical investigation plans.