Design History File (DHF)

Who Needs a Design History File?

Does Your Medical Device Have a Design & Development Process That Needs to Be Documented?

A Design History File (DHF) provides organized evidence of the design and development history of a medical device. It helps demonstrate how design requirements were established, developed, reviewed, verified, validated, and changed throughout the product development process.

Medsure Consulting supports medical device manufacturers in creating, organizing, reviewing, and remediating Design History Files based on the applicable regulatory and documentation requirements.

Medsure Can Support:

• New medical device manufacturers developing a DHF from the beginning

• Medical device startups developing new products

• Manufacturers preparing regulatory submissions

• Companies with an existing DHF requiring review

• Manufacturers with incomplete design documentation

• Companies undergoing design documentation remediation

• Manufacturers making design changes

• Companies needing stronger design traceability

• Manufacturers preparing for regulatory or quality assessments

Our Design History File Services

Discuss Your DHF Requirements

01 — Design & Development Documentation Strategy

We establish a structured approach for organizing design and development records based on the device, development stage, and applicable regulatory requirements.

02 — Design Planning Documentation

Support for documenting design and development activities, responsibilities, milestones, deliverables, and applicable review activities.

03 — Design Inputs & Design Outputs

Preparation and organization of documentation demonstrating how design requirements were established and translated into defined design outputs.

04 — Design Verification & Validation Documentation

Support for organizing verification and validation plans, protocols, reports, results, and supporting evidence.

05 — Design & Development Risk Documentation

Integration of relevant risk management activities and outputs with the design documentation.

06 — Design Review Documentation

Organization of documented design reviews and associated decisions, actions, and approvals.

Design History File Process

Discuss Your DHF Requirements

01 — Assess the Existing Documentation

Review available design and development records, product documentation, risk management information, and supporting evidence.

02 — Establish the DHF Structure

Define an appropriate structure for organizing design and development records and establishing documentation traceability.

05 — Verification & Validation

Compile evidence demonstrating that design outputs meet specified requirements and that the resulting device meets its intended use and user needs, as applicable.

07 — Compile the DHF

Bring the relevant records together into a structured and traceable Design History File.

04 — Document Design Outputs

Organize evidence demonstrating how design inputs were translated into specifications, drawings, manufacturing information, software outputs, or other applicable design deliverables.

06 — Design Reviews

Document formal reviews of the design and development process, including conclusions, decisions, and required actions.

03 — Document Design Inputs

Capture the requirements that define what the device is expected to achieve, including applicable functional, safety, performance, and regulatory requirements.

08 — Maintain Design Documentation

Support updates to the DHF when design changes, new verification or validation activities, risk changes, or other development activities affect the documented design history.

Frequently asked questions

What is a Design History File (DHF)?

A Design History File is a collection of records that demonstrates the design and development history of a medical device, including applicable planning, design inputs, outputs, reviews, verification, validation, and related documentation.

Why is a DHF important?

A structured DHF provides documented evidence of how a device was designed and developed and helps establish traceability between requirements, design decisions, testing, and final design outputs.

Can Medsure create a DHF from the beginning?

Yes. Medsure can support manufacturers in establishing a DHF structure and developing or organizing the applicable design and development documentation.

Can you review an existing DHF?

Yes. Medsure can perform a DHF gap assessment to identify missing, inconsistent, or incomplete documentation and recommend remediation activities.

Does the DHF include risk management documentation?

Relevant risk management documentation can be incorporated or linked within the DHF structure as appropriate to the device and applicable requirements.

Can DHF documentation support an FDA 510(k)?

Relevant design, verification, validation, and supporting documentation may contribute to the broader evidence package required for an FDA 510(k), depending on the device and submission strategy.

Can the DHF support CE Marking?

Yes. Relevant design and development evidence can support the broader technical documentation required for CE Marking under the applicable EU regulatory framework.

Need a Structured, Regulatory-Ready DHF?

Build your medical device design history on a stronger foundation.

Medsure Consulting helps manufacturers organize, develop, review, and improve Design History Files with a focus on documentation quality, traceability, and regulatory readiness.