Is CertHub a document management system?

No. Documents display data. They should not be where the data lives. CertHub keeps intended purpose, risks, evidence, and process data in one governed model, then generates technical documentation, QMS, and submissions from approved data and templates.

Do you replace the Notified Body?

No. Conformity Checks tell manufacturers what a Notified Body is likely to find before assessment. Auditor Co-Pilot supports Notified Body reviewers. The human remains the decision-maker. CertHub does not replace conformity assessment by a Notified Body.

Do you ship raw AI as the file?

No. AI helps prepare and check work against the governed model. What leaves for review is approved structured data and generated documentation, with a human as decision-maker. Not an unreviewed model dump.

Both sides of the submission. One structured model.

CertHub is the AI-native compliance platform that connects MedTech manufacturers and Notified Bodies through structured regulatory data, so reviews move faster and every filing starts from the same spine.

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The position

A digital bridge built on structured data.

Not another document pile. One governed model for manufacturers and Notified Bodies. And a clear line on where we do not play.

Digital bridge, both sides

Structured regulatory data for manufacturers, assessment workflows for Notified Bodies, so reviews move with greater transparency.

Structured data, not documents as the source of truth

Intended purpose, risks, evidence, and process data live in one model. Documents and submissions are generated from approved data.

From regulatory experts

Designed with people who have been through the audits, for the people who run them. Meet them on About.

Where we do not play

Not a document management system. We do not replace the Notified Body. We do not ship raw AI as the file.

Built with regulatory experts.

Leadership and in-house RA behind that claim. Full bios on About.

Meet the team

In the work the industry is doing together.

CertHub builds the platform. It also takes part in how regulatory data is structured, and how AI belongs in Regulatory Affairs.

MDKU and DIN SPEC 91509

Member of Medical Device Knowledge Units, and part of the work that designed the open data model now published as DIN SPEC 91509. Release 1 covers intended purpose. The specification is free to use, and after the pilot it is intended to feed a European standard for technical documentation.

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Founding organisation of SARA

Society for AI in Regulatory Affairs, founded with Hoodin and MedTech Leading Voice. A neutral forum for Regulatory Affairs and Quality: webinars, round tables, and writing from people who use AI in regulated work and can say where it holds up.

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Member of Medical Valley EMN

Part of the Medical Valley network, where manufacturers, clinics, and research in the Nuremberg region work on getting medical products to patients.

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Where we play, and where we don't

Short answers to the three lines buyers test first.

Where to go next

Explore how CertHub shows up.

Platform for manufacturers, Notified Bodies for assessment-side models, Trust for posture, About for the people.

Compliance Platform

One structured data model behind technical documentation, QMS, and global submissions.

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Notified Bodies

Auditor Co-Pilot and The Bridge. Assessment capacity with the human as decision-maker.

For Notified Bodies

Trust Center

German hosting, GDPR, ISO 27001, and ISO 80002-2 validation in one place.

Open Trust Center

About CertHub

Leadership, in-house RA, and the advisory bench. The people who know regulation.

Meet the team

Next step

See the structured model on your data.

Book a demo, or open the platform overview if you want the full product map first.

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