No more painful paper work to launch your MDR / IVDR medical products by automating the regulatory processes with our next-level Digital QMS and Technical Documentation solution
Compliance is mandatory
Complexity is not.
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
CEO • Business Development & Product
Leon has over ten years of industry experience in product development from Enterprise to StartUp developing compliant products ranging from dental diagnostics software, flying drones to surgical equipment. He has personally led the certification process for medical devices experiencing the challenges of our customers first-hand.
CTO • Technology & Product
Nicolas has years of experience developing AI-powered software for B2B SaaS companies, including medical software. Nicolas built and managed cloud software with 20 million users ensuring highest privacy, cybersecurity and data standards and developed medical software, experiencing first-hand the peculiarities of MDR regulation.
COO • Product, Sales & Operations
Jonas has substantial entrepreneurial experience as the founder of a SaaS company, where he managed a digital SaaS platform serving over 800 clients.
CertHub offers software for digital QMS and Technical Documentation to enable medical device manufacturers to launch their products years faster.
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