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 and pasting by maintaining all product information in one single source of truth.
Smart Document Creation: No more time waste by automatically aggregating content and format verification records, reducing time spent on regulatory documentation.
Audit-Ready with 1-Click: No more fear of audits by using standardized templates to generate audit-ready Technical Documents, and export them as PDFs with just a click.
Global Compliance Expansion: No more wait for entering into new markets by creating customized templates for various jurisdictions (e.g., MDR, FDA 510(k)) with your existing inputs, unlocking new markets with minimal effort.
Seamless Collaboration: Enable easy approvals with digital e-signatures, automatic notifications, reducing delays and keeping process moving.
Save Time: Automate task assignments and streamline workflows, allowing teams to focus on critical work.
Single Input Entry: Capture what you need and do the analytics directly by structuring collected data with a dynamic forms builder.
Reduce Errors: Eliminate missing data with pre-filled documentation and structured product information.
Aligned Teams: Seamlessly connect the different teams together by ensuring that operational teams actually use the content which are defined in the QMS.
Efficient Data Management: No more copy and pasting by maintaining all product information in one single source of truth.
Smart Document Creation: No more time waste by automatically aggregating content and format verification records, reducing time spent on regulatory documentation.
Audit-Ready with 1-Click: No more fear of audits by using standardized templates to generate audit-ready Technical Documents, and export them as PDFs with just a click.
Global Compliance Expansion: No more wait for entering into new markets by creating customized templates for various jurisdictions (e.g., MDR, FDA 510(k)) with your existing inputs, unlocking new markets with minimal effort.
Seamless Collaboration: Enable easy approvals with digital e-signatures, automatic notifications, reducing delays and keeping process moving.
Save Time: Automate task assignments and streamline workflows, allowing teams to focus on critical work.
Single Input Entry: Capture what you need and do the analytics directly by structuring collected data with a dynamic forms builder.
Reduce Errors: Eliminate missing data with pre-filled documentation and structured product information.
Aligned Teams: Seamlessly connect the different teams together by ensuring that operational teams actually use the content which are 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
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