Is your Design History File audit-ready? Many medical device manufacturers face warning letters, 483s, or delays in approvals due to gaps in their DHF documentation. At Elexes, we specialize in DHF remediation services tailored to meet FDA, ISO 13485, and EU MDR requirements.
Whether you’re preparing for a product submission or correcting legacy files, our experts ensure your documentation reflects design controls from planning through validation. Let us help you remediate with confidence and clarity.
⦿ Avoid costly rework
⦿ Get audit-ready documentation
⦿ Meet global regulatory standards
A non-compliant DHF doesn’t just risk regulatory penalties, it can also compromise patient safety and delay product launches. Whether due to outdated formats, missing traceability, or inadequate risk documentation, these gaps must be resolved proactively.
Elexes’ DHF remediation experts work closely with manufacturers to identify and fix such deficiencies in line with 21 CFR Part 820, ISO 13485:2016, and MDR Annex II. We make sure your design inputs, outputs, risk management, and V&V data are aligned and complete.
With years of experience across Class I, II, and III devices, including SaMD and IVDs, we offer remediation that stands regulatory scrutiny.
Whether you are starting from a gap analysis or responding to a 483 observation, our Design History File remediation process is comprehensive. From verifying trace matrices to compiling missing usability studies and updating legacy design controls, we do it all.
We offer:
⦿ DHF gap assessment and remediation strategy
⦿ Compilation of missing design control documentation
⦿ Traceability matrix creation (Input–Output–Verification–Validation)
⦿ Risk management documentation per ISO 14971
⦿ Review and update of labeling, IFUs, and software elements
Our team ensures every update is traceable, justified, and audit-ready without disrupting your development timelines.
Free PDF: DHF Remediation Checklist for Medical Device Companies
Covers traceability, risk documentation, software DHF, labeling, and more.
With Elexes, you get more than just corrections. You get regulatory foresight and engineering expertise in one team.
We begin with a detailed evaluation of your current DHF against relevant regulatory standards like FDA’s QSR, ISO 13485, and MDR. We flag incomplete, outdated, or missing elements for targeted action.
We help generate or revise documentation to align with ISO 14971 and IEC 62366, ensuring your DHF reflects the intended use and mitigates identified hazards.
No two medical devices are the same. Our team creates a device-specific remediation plan outlining required updates, ownership, and timelines to achieve full compliance.
The final DHF is organized, indexed, and compliant—ready for FDA inspection, ISO audits, or Notified Body reviews, reducing back-and-forth and potential findings.
We establish full traceability between design inputs, outputs, risk controls, V&V, and software elements. This is one of the most common gaps in regulatory reviews.
These visual aids offer a snapshot of where most DHFs fall short and how Elexes brings them up to standard.
Don't let a weak DHF hold you back, secure compliance today. Schedule a Free Consultation Now
DHF remediation is the process of correcting or updating a Design History File to ensure compliance with regulatory requirements like FDA 21 CFR 820, ISO 13485, and MDR.
Remediation is required when gaps are identified during audits, inspections, or as part of new submissions for legacy devices.
Timelines vary depending on device complexity and the number of gaps, but can range from 2 to 20 weeks.
Our experts will help you identify insufficiencies, determine inspection readiness, and evaluate risks, smoothing the inspection process and providing a greater chance of successful inspection. We will conduct periodic internal audits to ensure compliance with all the applicable ISO standards, cGMPs and internal regulations. Be it short targeted internal audits or more sustainable assessments across the quality management system (QMS), we have experts who can conduct a thorough audit and come up with any compliance gap that needs to be worked on.
Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.
Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.
We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.
Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.
Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.
Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.
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 -
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