Description:

This DHF form helps us compile and keep control of design control evidence in one place across the full device lifecycle.
• Define Project Name and DHF Number to anchor document traceability.
• Maintain an up-to-date DHF index of controlled deliverables and revisions.
• Link each record to the Traceability Matrix and related requirement IDs.
• Capture key design control outputs: Design Inputs, Design Reviews, and Design Changes.
• Reference objective evidence for Design Verification and Design Validation activities.
• Confirm transfer-ready records supporting Design Transfer and production readiness.

Your needs:

• design history file aligned with ISO 13485 requirements
• design history file with traceability of design changes
• Reduce audit risk by keeping DHF evidence complete, current, and easy to navigate.

Use this form when you need a practical, living overview of your Design History File, from project initiation through transfer and release, so teams can find the latest approved records fast.

This DHF form captures what must be controlled and traceable. A DHF is the organized set of design control records, and a Traceability Matrix shows how requirements map to evidence and decisions.
• List controlled records with document number, revision, and status.
• Maintain linkage to requirements and verification/validation evidence.
• Ensure design reviews and action closures are recorded and retrievable.
• Track design change impacts and approved updates to DHF contents.
• Support transfer readiness with clear production-facing document references.

Within Lexqara, we help structure DHF content, align traceability, and prepare audit-ready design control packs. Explore our Resource Center and our Design Control Support for Start-up Companies, and benchmark expectations via FDA Design Controls. Request a short DHF gap assessment.

A well-maintained DHF reduces rework, accelerates internal decisions, and makes external reviews smoother by keeping evidence consistent and easy to verify.