Maintain all of your product content only once.No inconsistencies and redundant entery anymore
Connect your product data to NB-specific templates tocreate your TD in Minutes/push of a button
Adapt your existing content to different use cases with just 1-click
Customize your existing application content to MDR, FDA 510(k), Anvisa, PMD Act and unlock the new markets with just 1-click
Secure all the versions and monitor the updates in each step of your product development process
Search the information you need in all your existing PDFs/Word/Scan documents and instantly find exactly what you need
Single Source of Truth: Centralize structured product and company data to eliminate inconsistencies.
No More Manual Work: Stop copying and pasting—reuse information across documents automatically.
High Transparency & Traceability: Give quality and regulatory teams easy access to find, edit, and manage data efficiently.
Right Content to Submission: Pre-check if everything is correct with the right documents and content for submission.
Create Documents Magically: Generate documents effortlessly using the Smart Editor.
Reference the Single Source of Truth: Link product data and QMS to manage and reuse content across documents.
Automated Data Transformation: Transform verification records into lists automatically, saving hours of formatting for quality and regulatory teams.
Full Formatting Support: Effortlessly handle images, tables, and familiar styles—export content to PDF in your preferred format.
Automated Template Filling: Enter your product and company info, and the document is generated automatically.
Audit-Ready at a Click: Use pre-built structure or define your own include external test reports.
Standardized or Custom Templates: Use prepared templates aligned with Notified Body expectations or add your own for different products.
Efficient Documentation Creation: Generate sections based on product data, cutting down manual work.
Customized Templates: Create tailored templates for MDR, FDA 510(k), Anvisa, PMD Act, and other regulatory frameworks.
Multi-Jurisdictional Use: Reuse product data across jurisdictions, simplifying regulatory maintenance.
Effortless Compliance: Maintain compliance with ease across different regions by leveraging existing data.
Track Development Over Time: Get insights into product and process changes, now and in the future.
Prove Product Evolution: Confidently demonstrate how your product has evolved during development and maintenance cycles.
Version Control: Maintain continuous version control to easily access and jump to previous versions.
Audit-Ready: Quickly showcase compliance in audits with detailed version histories.
Natural Language Interaction: Ask questions in plain language through the search wizard for quick access to information.
Data-Driven Search: AI Assistant scans company, product data, and external PDFs like clinical evaluations to deliver precise results.
Quick Overview: Get a concise summary of relevant information quickly.
Direct Navigation: Be guided directly to the right place to continue working on detailed tasks
Single Source of Truth: Centralize structured product and company data to eliminate inconsistencies.
No More Manual Work: Stop copying and pasting—reuse information across documents automatically.
High Transparency & Traceability: Give quality and regulatory teams easy access to find, edit, and manage data efficiently.
Right Content to Submission: Pre-check if everything is correct with the right documents and content for submission.
Create Documents Magically: Generate documents effortlessly using the Smart Editor.
Reference the Single Source of Truth: Link product data and QMS to manage and reuse content across documents.
Automated Data Transformation: Transform verification records into lists automatically, saving hours of formatting for quality and regulatory teams.
Full Formatting Support: Effortlessly handle images, tables, and familiar styles—export content to PDF in your preferred format.
Automated Template Filling: Enter your product and company info, and the document is generated automatically.
Audit-Ready at a Click: Use pre-built structure or define your own include external test reports.
Standardized or Custom Templates: Use prepared templates aligned with Notified Body expectations or add your own for different products.
Efficient Documentation Creation: Generate sections based on product data, cutting down manual work.
Customized Templates: Create tailored templates for MDR, FDA 510(k), Anvisa, PMD Act, and other regulatory frameworks.
Multi-Jurisdictional Use: Reuse product data across jurisdictions, simplifying regulatory maintenance.
Effortless Compliance: Maintain compliance with ease across different regions by leveraging existing data.
Track Development Over Time: Get insights into product and process changes, now and in the future.
Prove Product Evolution: Confidently demonstrate how your product has evolved during development and maintenance cycles.
Version Control: Maintain continuous version control to easily access and jump to previous versions.
Audit-Ready: Quickly showcase compliance in audits with detailed version histories.
Natural Language Interaction: Ask questions in plain language through the search wizard for quick access to information.
Data-Driven Search: AI Assistant scans company, product data, and external PDFs like clinical evaluations to deliver precise results.
Quick Overview: Get a concise summary of relevant information quickly.
Direct Navigation: Be guided directly to the right place to continue working on detailed tasks
CertHub offers AI-fueled software solutions for Technical Documentation, QMS and Design Control - tailored to the MedTech industry.
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