A well-maintained Design History File (DHF) is essential for demonstrating compliance with regulatory requirements. At confinis, we assist clients in creating and organizing DHFs for both new development projects and remediation efforts. Our experts ensure that all documentation, from initial design inputs to final design outputs, is comprehensive and meets regulatory standards.

We guide clients through the process of compiling all necessary documents, including design plans, risk management files, verification and validation reports, and change control records. Our approach ensures that the DHF is complete, easily accessible, and ready for regulatory audits. This not only facilitates compliance but also supports efficient project management and product development.