⦿ During FDA premarket submissions (510(k), PMA)
⦿ When seeking ISO 13485 certification
⦿ Before or during FDA inspections
⦿ As part of internal design control compliance
⦿ During MDSAP or EU MDR QMS evaluations
At Elexes, we provide specialized services to help develop and maintain a compliant Design History File (DHF) for medical device manufacturers that aligns with FDA 21 CFR Part 820.30 and ISO 13485 requirements. Whether you're launching a new device or preparing for an audit, our DHF services ensure your documentation is thorough, traceable, and inspection-ready.
⦿ A Design History File (DHF) is not just a compliance requirement, it’s a strategic asset in the lifecycle of a medical device. Required under FDA 21 CFR 820.30(j) and referenced in ISO 13485:2016, the DHF contains documentation demonstrating that your device was developed according to the approved medical device design plan and medical device design control requirements.
⦿ Whether you're launching a new medical device in the U.S. or preparing for an ISO 13485 audit, your Design History File for medical devices serves as proof of due diligence and quality. At Elexes, we specialize in compiling and maintaining complete, audit-ready DHFs that align with both FDA and international regulatory standards.
At Elexes, we help ensure that all required elements of your DHF are present, complete, and organized. We not only compile your DHF but make every single document that goes into your DHF. Your DHF will include:
⦿ Design and Development Plan: Structured roadmap aligned with the development lifecycle.
⦿ Design Inputs: User needs and regulatory requirements transformed into measurable specifications.
⦿ Design Outputs: Drawings, specs, and manufacturing procedures that define the final product.
⦿ Design Reviews: Formal checkpoints ensuring completeness and resolution of issues.
⦿ Design Verification & Validation: Evidence that the device meets input requirements and performs as intended in real-world conditions.
⦿ Design Changes: Documented modifications, their rationale, and impact assessments.
⦿ Risk Management Records: Integration with ISO 14971 risk documents (as applicable).
Elexes ensures your Design History File for medical devices reflects a seamless integration of engineering, quality, and regulatory perspectives.
Whether you're starting from scratch or retroactively compiling a DHF, Elexes provides tailored support through:
Identify missing, inconsistent, or outdated documentation.
From templates to custom documentation, we prepare everything to meet FDA/ISO standards.
Establish clear traceability from design inputs to outputs, verification, and validation.
Engage design, manufacturing, and QA/RA teams for unified documentation.
Prepare your DHF for regulatory audits or premarket submissions.
Our team ensures that your Design History File for medical devices is both compliant and strategically valuable.
Elexes offers comprehensive support for creating, reviewing, and maintaining your Design History File for medical devices, helping you meet FDA and ISO 13485 design history file requirements with ease. Our core services include:
Your DHF will be professionally indexed, searchable, and inspection-ready for any audit.
Stay compliant as your product evolves, our team manages DHF updates in real-time.
From design planning to final validation, we build a compliant and audit-ready DHF tailored to your device and development stage.
We identify missing or non-compliant elements in existing DHFs and correct them to meet regulatory standards.
Clear mapping of design inputs to outputs, verification, and validation ensures documentation traceability.
We align your DHF with ISO 14971 risk management and usability engineering documentation for a holistic regulatory package.
With Elexes, your Design History File for medical devices won’t just be a box to check, it’ll be a strategic tool for faster approvals and smoother audits.
Learn more about our regulatory consultant services here.
Gain clarity on DHF, DMR, and DDF distinctions, plus a visual walkthrough of our DHF creation process.
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
CEO Masterlink, Arizona
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MD Blackrock Pharma, England
VP Regulatory AliveCor, California
Owner Liz Inc., Arizona
CEO Radformation, New York
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