1-Click Documentation eTD + eQMS

Regulatory teams (QM & RA) managing MDR/IVDR documentation regardless of company size in Word/Excel or old-fashioned eQMS and DMS tools.

Problem

Manual document creation is repetitive, error-prone, and hard to keep consistent. Teams working on document level and not just directly in content/data.

Solution

Next-Gen eQMS AND eTD solution CertHub. Whether you're developing a new medical device or moving a mountain of legacy files and countless product variants, it is a pleasure to maintain and update your products and QMS in CertHub – fully compliant with MDR, IVDR and more.

More resources for what matters...

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faster TechDoc submission

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changes reflected in all documents

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copy paste work

What's inside

Legacy Document Transfer

We extract knowledge from your existing Word and Excel documents and transform the information into our structured Knowledge Model with AI – creating instant value and empowering your team.

CertHub's Knowledge Model

Tell our Knowledge Model about your product, and CertHub automatically selects the right templates – from risk management to IFUs and clinical evaluation – powered by our regulatory logic.

Live Update Propagation

With CertHub, a single change – such as a risk or intended purpose – updates all connected documents and submissions automatically. Teams stay informed, and fresh versions are ready immediately. We handle the heavy lifting, ensure every file is traceable, and keep you submission-ready with total confidence for any minor and major product change.

One-Click Document Generation

With a single click, CertHub builds your entire TechDoc package (PDFs, Markdown, HTML, ZIPs, etc.) while keeping ever paragraph fully traceable to its source.

Assess your regulatory compliance maturity!

Want to know, if you are ready for regulatory technology? Find your maturity score and talk to our expert about what AI in compliance can do today.

Assessment Progress

Complete all questions to see your maturity score

Average Score

How open is your organization to adopting new digital tools and processes for compliance?

/10

To what extent does your current IT infrastructure support the implementation of digital compliance solutions?

/10

How well structured and accessible is compliance-related data across your organization?

/10

How standardized and documented are your compliance processes (e.g., SOPs, risk management, CAPA)?

/10

Do you already have digital systems (e.g., QMS, document management, workflow tools) in place to support compliance?

/10

How well integrated are your compliance tools with other enterprise systems (e.g., ERP, CRM, PLM)?

/10

To what degree are compliance activities (e.g., document control, audits, training records) automated within your organization?

/10

How systematically does your organization review and update compliance processes to meet evolving regulatory requirements?

/10

We’ll walk you through...

Let's find out more about CertHub and see the 1-Click Documentation in action.