Post-launch support that keeps products compliant and on the market — and remediation of legacy Design History Files.
Stay compliant after launch.
We support the commercial phase — complaint intake and investigation, root-cause analysis, post-market surveillance, design changes, and periodic risk review — so the file stays current and issues are closed before they escalate.
Close the gaps before auditors do.
For legacy or acquired products, we assess the existing Design History File against current expectations, identify gaps in design controls, risk, and V&V, and rebuild the documentation to a defensible, audit-ready state.
Contact us to assess a legacy file and rebuild it to an audit-ready standard.
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