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Cut your manual work
with our Digital Technical Documentation

Save up to 60% of your time by just entering the necessary content only once to make your documents audit-ready by the push of a button

Single Source of Truth

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.

Single Source of Truth

Smart Editor

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.

Smart Editor

Submission Ready Templates

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.

Submission Ready Templates

Unlock New Markets

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.

Unlock New Markets

Versioning & Revision Control

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.

Versioning & Revision Control