Compliance is mandatory.
Complexity is not.

Focus on meaningful work to launch medical products years faster by automating regulatory processes with our digital QMS and Technical Documentation

CertHub is the only open platform for digital QMS and Technical Documentation

Integrate your proven QMS and technical documentation content into CertHub and take it to the next level!

If you don't have a QMS and technical documentation yet, we'll guide you through the process and provide you with our partners' ready-to-use SOPs, work instructions and forms, as well as a built-in technical documentation to get you started.

Launch your products years earlier

CertHub makes regulatory work and compliance easier and faster. So SMEs like you can launch products 60% faster and and save additional 30% on continuous compliance.

CertHub supports product class I, IIa, IIb and III

Flexible Templates to keep your proven structure

Build your own templates and schema with CertHub with all benefits of the Digital QMS and Technical Documentation. If you are starting from scratch, you can rely on our partners' validated and integrated QMS templates.

Become audit ready with the press of a button

Maintain your product and company data once and CertHub orchestrates it to the right document to create audit-ready documents automatically after all required information is available

Minimize manual effort and focus on value-adding tasks

CertHub keeps track of your daily work, shows missing data to reduce human error, reminds your colleagues to get trainings for specific processes and automatically notifies them when their expertise is required

CertHub combines digital QMS and Technical Documentation as the #1 operating system for regulatory and compliance work

Digital QMS

Streamline regulatory workflows across the entire organization with living SOPs, work instructions, and forms that automatically notify colleagues when input (e.g., signature) is required.

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Digital Technical Documentation

Enter content once as a single source of truth and export all required documents, records, and historical data with the click of a button. Even for different jurisdictions and Notified Body schemes. For 100% confidence in the audit.

CertHub has customers ranging from software to hardware products with risk classes I, IIa, IIb and III

→ Learn more about digital TD