Remediation is a program, not a document exercise. We run large remediation programs, including design controls and design history file (DHF) rebuilds, to plan and to budget.
A DHF rebuild is the hard case. The product exists, the evidence trail does not, and an auditor will ask for it. The work is to reconstruct what design controls required, close the gaps with real records, and leave a file that stands up on its own.
A quality management system (QMS) remediation applies the same discipline at larger scale. Scope is set up front, work is sequenced, and progress is reported against the plan and the budget so leadership sees where the program stands without asking.
Our people ran quality inside device companies before they audited anyone else's, and the team has completed more than 300 audits against FDA, ISO, MDSAP, and other global regulations. That shapes what we build: records an auditor can follow.
When to call us
- “Our design history files do not hold up.”
- “Our quality system needs a rebuild, not a patch.”