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 software for digital QMS and Technical Documentation to enable medical device manufacturers to launch their products years faster.
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