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: Manage all your structured product and company data in one centralized location to reduce inconsistencies.
No More Manual Work: Eliminate the need to copy and paste information across documents.
High Transparency & Traceability: Ensure colleagues from quality and regulatory affairs can easily find, access, and edit data with enhanced efficiency.
Right Content to Submission: Pre-check if everything is correct with the right documents and content for submission.
Create Documents Magically: Use the Smart Editor to effortlessly generate documents with minimal effort.
Reference the Single Source of Truth: Reference product data and QMS to manage content in one place and reuse it across multiple documents.
Automated Data Transformation: Aggregate entire verification records automatically and transform them into lists, saving hours of formatting for quality and regulatory affairs teams.
Full Formatting Support: Enjoy seamless support for images, tables, and all familiar formatting styles. Make it easier to export content the format/way you like as PDF.
Automated Template Filling: Only enter your product company info and the document will be 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: Automatically generate sections of the documentation based on product data, reducing manual work.
Customized Templates: Create tailored templates for MDR, FDA 510(k), Anvisa, PMD Act, and other regulatory frameworks.
Multi-Jurisdictional Use: Reuse the same product data across multiple jurisdictions, simplifying regulatory maintenance.
Effortless Compliance: Maintain compliance with ease across different regions by leveraging existing data.
Track Development Over Time: Gain insights into product and process changes, even years into 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 natural language through the search wizard for easy access to information.
Data-Driven Search: Smart AI Assistant searches across all company, product data and external PDFs such as clinical evaluation to provide accurate 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: Manage all your structured product and company data in one centralized location to reduce inconsistencies.
No More Manual Work: Eliminate the need to copy and paste information across documents.
High Transparency & Traceability: Ensure colleagues from quality and regulatory affairs can easily find, access, and edit data with enhanced efficiency.
Right Content to Submission: Pre-check if everything is correct with the right documents and content for submission.
Create Documents Magically: Use the Smart Editor to effortlessly generate documents with minimal effort.
Reference the Single Source of Truth: Reference product data and QMS to manage content in one place and reuse it across multiple documents.
Automated Data Transformation: Aggregate entire verification records automatically and transform them into lists, saving hours of formatting for quality and regulatory affairs teams.
Full Formatting Support: Enjoy seamless support for images, tables, and all familiar formatting styles. Make it easier to export content the format/way you like as PDF.
Automated Template Filling: Only enter your product company info and the document will be 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: Automatically generate sections of the documentation based on product data, reducing manual work.
Customized Templates: Create tailored templates for MDR, FDA 510(k), Anvisa, PMD Act, and other regulatory frameworks.
Multi-Jurisdictional Use: Reuse the same product data across multiple jurisdictions, simplifying regulatory maintenance.
Effortless Compliance: Maintain compliance with ease across different regions by leveraging existing data.
Track Development Over Time: Gain insights into product and process changes, even years into 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 natural language through the search wizard for easy access to information.
Data-Driven Search: Smart AI Assistant searches across all company, product data and external PDFs such as clinical evaluation to provide accurate 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 software for digital QMS and Technical Documentation to enable medical device manufacturers to launch their products years faster.
© CertHub 2024