An incomplete or outdated design history file (DHF) can stall even the strongest device submission. Our DHF remediation services bring your documentation up to standard so you can move forward with confidence — clear, compliant, and audit-ready.
If your DHF is incomplete, outdated, or hard to follow, your submission may face rejection even if the device itself is sound. The result? Approval delays, added costs, and potential damage to your credibility. Vantage MedTech helps you avoid these setbacks with DHF remediation services designed to keep your documentation audit-ready, compliant, and reflective of how your product was really developed.
A DHF is more than a regulatory requirement. It’s the story of how your product was built — the decisions made, risks managed, and processes followed to bring a safe, effective device to market. With Vantage as your partner, you can demonstrate that integrity and rigor with confidence.
DHF remediation is often required at key points in a product’s lifecycle. Common triggers include preparing for FDA or EU MDR submissions, transitioning legacy products from MDD to MDR, addressing gaps identified during audits, and updating documentation after design or risk management changes. Taking action early helps keep submissions, audits, and growth initiatives on track.
Neglecting remediation creates real regulatory and business risks:
Even a technically sound device can be held back by documentation issues. Gaps in the DHF may obscure design decisions, verification methods, or risk management activities. These flaws can create uncertainty about whether your team followed proper design controls.
By contrast, timely remediation delivers tangible advantages:
By addressing gaps proactively, your team can spend less time reacting to regulatory questions and more time advancing product development. Audit-ready DHFs also help demonstrate organizational rigor, improving stakeholder confidence and positioning your product for long-term success.
We partner closely with your team to bring your DHF up to applicable standards, guidance and regulations. Traceability from standards, guidance, and regulations to requirements at every level, to risk assessments and to verification and validation testing is key to the demonstration of completeness and to creating a roadmap for assessing the impact of changes and updates. Traceability is one of the very first things a reviewer or auditor will look for in assessing the quality and completeness of a DHF.
Using our Polarion ALM tools and document control system best practices, we strengthen traceability, keep records organized, and ensure processes are transparent. The result is not patchwork fixes, but clean, compliant documentation that reflects your device’s rigorous design and development.
Our remediation approach includes:
We also incorporate collaborative workflows, audit trails, and structured templates that make DHFs easier to maintain over the product lifecycle. These tools reduce confusion, simplify updates, and help your team stay aligned with regulatory expectations.
Our DHF remediation services scale to meet the needs of:
Whether you need full DHF development or selective remediation, our services align with your product’s complexity, risk profile, and market goals.
If your product is complex, your remediation will be too. Most DHF remediation services for electromechanical devices take weeks to several months, depending on product complexity and submission deadlines. The key is starting early so documentation doesn’t become the bottleneck. We move fast, but we also get it right.
Even cleared devices can benefit from remediation to ensure legacy documentation is traceable, consistent, and ready for post-market updates.
Yes — our teams have experience across software-driven, electromechanical, and implantable systems.
We integrate document control systems and tools like Polarion ALM to ensure every design input, output, and verification step is linked and auditable.
Don’t wait for an FDA inspection or surprise audit to discover gaps in your DHF. Vantage MedTech provides DHF remediation services and regulatory gap analysis to keep your documentation audit-ready, compliant, and aligned with how your product was truly developed.
Contact us today to schedule a DHF readiness check or regulatory gap analysis, or explore case studies showing how we’ve helped teams stay compliant, confident, and ready for market.
Vantage MedTech is proud to be recognized for our certified excellence in medtech innovation and manufacturing.
* Held by RBC Medical Innovations
** Held by Sterling Medical Devices