Regulatory compliance made simple.

A high-tech initiative for European medical device & in-vitro diagnostic manufacturers.

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The new standard for technical documentation.

Designed to simplify TD creation and maintenance, ultimately accelerating (re)certification processes.

Reduced manual work

50%

reduced manual work through cross document automations, eliminating repetitive tasks.

Faster submissions

70%

faster submissions through automated document reviews and real-time error detection.

in collaboration with Auditors, manufacturers, and industry experts.

Addressing the biggest compliance inefficiencies in the medical device industry.

40%

of EU applications reviewed by NBs are incomplete or contain non-conformities.

13-18

months on average to access the EU market - twice as long as under directives.

50%

of medical device manufacturers will reduce their product portfolio significantly.

*Based on data by European Comission, 2025

Key solutions designed with industry stakeholder.

Manufacturers

Save time, reduce manual work, and ensure compliance in your documentation processes, allowing you to focus on innovation and faster market access.

Notified Bodies

Simplify and accelerate reviews with accurate, pre-verified technical documentation, ensuring faster internal processes and a fast-tracked certification for manufacturers.

Consultancies

Deliver exceptional service with a dedicated platform and tools that enhance internal consulting efficiency, reduce errors, and improve client outcomes.

The industry solution.

Purpose-built with industry stakeholders.

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