A complete, audit-ready Design History File and risk management to ISO 14971 — structured to withstand FDA and Notified Body scrutiny from day one.
Documentation that withstands audit.
We construct and maintain the full DHF — design inputs and outputs, design reviews, traceability matrices, and verification and validation records — structured so an FDA investigator or Notified Body auditor can follow the thread from user need to finished device without gaps.
From hazard analysis to risk-benefit.
We lead the risk management file end to end: hazard analysis, dFMEA, uFMEA, and pFMEA, risk controls, and residual risk-benefit conclusions — integrated with your human factors use-related risk analysis and maintained across the product lifecycle.
Contact us to structure or remediate your Design History File and risk management program.
Schedule Consultation