DHF Readiness, Review, Remediation

The Design History File (DHF) is the documented record demonstrating how a medical device was designed, developed, verified, and validated. It provides regulators with evidence that design controls were properly implemented and that the device was developed in a controlled and traceable manner.

For many organizations, weaknesses in the DHF do not become visible during internal development. They often emerge during regulatory submission preparation, when teams must demonstrate clear traceability between requirements, risk controls, verification activities, and design decisions.

Incomplete documentation, fragmented traceability, and inconsistent lifecycle records can introduce significant delays during regulatory review.

Frelong Health helps organizations evaluate and strengthen their Design History Files before these issues become regulatory obstacles.

DHF Readiness Assessment

We perform structured reviews of Design History File documentation to determine whether the existing development record can support regulatory submission or external audit. This assessment examines the alignment between design inputs, design outputs, risk management activities, and verification evidence.

The objective is to determine whether the documentation clearly demonstrates that design controls were implemented throughout the development lifecycle.

Traceability and Lifecycle Review

Regulators expect manufacturers to demonstrate clear traceability between system requirements, software requirements, risk controls, and verification results.

Frelong Health evaluates the structure of existing documentation and traceability artifacts to identify gaps, inconsistencies, or areas where lifecycle evidence is incomplete or difficult to defend during regulatory review.

Targeted DHF Remediation

When gaps are identified, we assist teams in correcting documentation and strengthening lifecycle records so the Design History File accurately reflects the development process.

This work may include restructuring traceability frameworks, aligning verification documentation with design inputs, clarifying design review records, or strengthening risk management integration.

Our goal is not simply to produce additional documents but to ensure the development record provides a clear and credible account of how the device was designed and validated.

Submission Preparation Support

As organizations approach regulatory submission, the DHF often becomes the primary source used to support design control sections of the submission.

Frelong Health assists teams in preparing the documentation needed to demonstrate that development activities were performed under appropriate controls and that the device meets its intended use and safety expectations.

Result

The result is a Design History File that clearly demonstrates design control implementation, supports regulatory submission requirements, and provides a defensible development record during regulatory review or external audit.