Design Freeze should be a launchpad, not a roadblock.
We help ensure your documentation is complete, your risk files are up to date, and your submission is ready to move forward. Our team ensures your design documentation reflects the work you’ve done, and anticipates the questions regulators will ask. We align your files, processes, and systems so that your product and paperwork are ready to move forward together.
Prepare and organize Design History File (DHF) content
We ensure your DHF reflects the current state of your product and is ready for regulatory review. A well-prepared DHF tells a clear story of your product’s development, and demonstrates that design controls were followed. We don’t just check boxes; we make sure your file aligns with reviewer expectations, reduces questions, and supports a smooth path to clearance.
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Design History & Risk Management
Risk Management
QMS Implementation
- Review design inputs/outputs for traceability
- Ensure verification and validation activities are documented
- Organize the DHF for submission-readiness
Validate usability and human factors documentation
We guide your team through formative and summative testing to meet FDA expectations. Usability issues can delay approval or lead to rework if not properly addressed. We help you interpret study results, integrate findings into design documentation, and ensure your usability evidence satisfies both FDA and international standards.
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Human Factors & Usability Studies
Clinical Study Support
Submission Management & Acceleration
- Assess test protocols and results
- Connect usability findings to design changes
- Ensure compliance with IEC 62366-1 and FDA guidance
Evaluate submission readiness and documentation gaps
Don’t freeze design until you’ve reviewed every dependency. Even small inconsistencies in documentation can raise red flags. We perform deep reviews to identify issues before the FDA does, so you can move into submission with confidence, knowing your package is complete, aligned, and defensible.
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Submission Management & Acceleration
Pre-Submission & FDA Negotiations
Regulatory Submission Automation & Traceability
- Conduct document gap assessments
- Recommend missing risk mitigations or controls
- Align documents with FDA content structure (e.g. eSTAR, 510(k) checklists)