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Static PDFs Are Dead. Go Live.

Technical files shouldn't be snapshots. Live Link keeps your Design History File (DHF) and Technical File updated in real-time as engineering data changes.

Deep Linking

Click a requirement in the Essential Requirements Checklist (GSPR) and jump straight to the specific test result paragraph.

Change Propagation

Change a spec in the Design Input? The system flags all impacted verification tests and risk items automatically.

Instant Export

Generate a perfectly formatted, paginated, and indexed PDF Technical File for submission at any moment.

Dynamic Documentation Engine

01

Map Structure

Define your Tech File structure (STED, IVDR, MDR) using our templates.

02

Link Evidence

Connect data sources (Jira, Google Drive, OneDrive). Don't copy-paste; just link.

03

Monitor Health

Dashboards show document completeness and expiration status of linked evidence.

System Specs

TemplatesMDR Annex II/III, FDA 510(k)
ConnectorsJira, Confluence, SharePoint
TraceabilityMatrix View (Requirements to Test)
ExportPDF with Hyperlinks
VersioningGit-style version control
SearchFull-text OCR search

FAQ

Q. Does it work with Word files?
A. Yes, it can wrapper existing Word files while you transition to structured data.
Q. Can auditors access this?
A. You can give 'Read-Only' access to auditors, or send them the exported PDF.
Q. Is it validated?
A. Yes, validated for creation of quality records under 21 CFR Part 11.