No more painful paper work to launch your MDR / IVDR medical products with our next-level Digital QMS and Technical Documentation solution leveraging latest AI technologies
Compliance is mandatory
Complexity is not.
Hear from our customers!
Managing Director & CTO of Elixion Medical GmbH
Outstanding support, robust AI features and great usability. It's rare to find a product that really delivers and is a joy to work with.
Efficient Data Management: No more copy-paste. Keep all product information in one single source of truth.
Smart Document Creation: No more time waste. Automatically aggregate content and format verification records to cut down time on regulatory docs.
Audit-Ready with 1-Click: No more audit fear. Generate audit-ready Technical Docs from templates and export them as PDFs in one click.
Global Compliance Expansion: No more delays. CertHub reuses your existing inputs to generate tailored templates for MDR, FDA 510(k), and more—unlocking new markets with minimal effort.
Seamless Collaboration: Enable smooth approvals. Digital signatures and automatic notifications reduce delays and keep processes moving.
Save Time: Automate tasks. Streamline workflows so teams can focus on what really matters.
Single Input Entry: Structure collected data with dynamic forms to capture exactly what you need and analyze it instantly.
Reduce Errors: No more missing data. Pre-filled docs and structured info ensure completeness.
Aligned Teams: Seamlessly connect teams. Ensure operational teams use the content defined in the QMS.
Efficient Data Management: No more copy-paste. Keep all product information in one single source of truth.
Smart Document Creation: No more time waste. Automatically aggregate content and format verification records to cut down time on regulatory docs.
Audit-Ready with 1-Click: No more audit fear. Generate audit-ready Technical Docs from templates and export them as PDFs in one click.
Global Compliance Expansion: No more delays. CertHub reuses your existing inputs to generate tailored templates for MDR, FDA 510(k), and more—unlocking new markets with minimal effort.
Seamless Collaboration: Enable smooth approvals. Digital signatures and automatic notifications reduce delays and keep processes moving.
Save Time: Automate tasks. Streamline workflows so teams can focus on what really matters.
Single Input Entry: Structure collected data with dynamic forms to capture exactly what you need and analyze it instantly.
Reduce Errors: No more missing data. Pre-filled docs and structured info ensure completeness.
Aligned Teams: Seamlessly connect teams. Ensure operational teams use the content defined in the QMS.
CertHub has customers ranging from software to hardware products with risk classes I, IIa, IIb and III with focus on SMEs
CEO and Co-Founder Kumovis (3D Systems)
Head of Translatum & TUM Chair of Biomedical Electronics Academic Director MedTech, Venture Labs Healthcare
Regulatory Affairs Manager HP Medizintechnik GmbH & MD at HP Med Consulting GmbH
Founder & CEO Ocumeda
Managing Director & Founder Evoleen
Head of QM & RA FRIZ Biochem GmbH
Executive Director Advanced Technology | Global Research & Development bei Karl Storz SE & Co. KG
Freelance Auditor for multiple Notified Bodies, Medical Device Expert
CertHub offers software for digital QMS and Technical Documentation to enable medical device manufacturers to launch their products years faster.
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