Quality Assurance and Regulatory Affairs
Design History File (DHF) Remediation
Achieve Complete DHF Integrity & Audit Readiness
A non-compliant Design History File (DHF) can result in compliance gaps and costly delays. Our DHF remediation services address issues such as outdated documentation, traceability gaps, and incomplete risk files, before they disrupt product launches or regulatory audits.
Our team works proactively with medical device manufacturers to identify and resolve deficiencies in line with key global standards, including 21 CFR Part 820, ISO 13485:2016, ISO 14971, IEC 62366-1, and MDR Annex II. We ensure your design inputs, outputs, risk management activities, and Design Verification and Validation (V&V) data are complete and consistent.
We have deep experience supporting Medical devices, In Vitro Diagnostics (IVDs), combination devices, and Software as a Medical Device (SaMD) to deliver documentation that can withstand regulatory scrutiny.
Our DHF Remediation Capabilities
DHF gap assessment and remediation strategy
Design control documentation with compilation of missing elements
Traceability matrix creation (design inputs, outputs, V&V)
Labeling, packaging, and Instructions for Use (IFU) review
Design dossier and technical file creation and remediation (as per 21 CFR Part 820, EU MDR / IVDR)
Verification and validation documentation support
Risk management documentation (per ISO 14971)
Resolve DHF gaps before they impact your audit.
Work with our specialists to achieve full documentation compliance.