DHF Remediation Support for Class I Medical Devices

DHF Remediation Support for Class I Medical Devices

A client came to Viltis needing Design History File remediation for its Class I medical devices. Changes to the European Medical Device Regulation meant the DHFs had to be updated to keep market access in Europe, and the deadlines were already tight when the work started.

Viltis deployed Quality Engineers to work directly with the client's quality and regulatory teams. They brought medical device development experience and working knowledge of EU MDR, IVDR, FDA 21 CFR Part 820, and ISO 13485.

Approach

Reviewed existing DHFs and documented compliance gaps.

Worked with R&D, Quality Assurance, Regulatory Affairs, and Clinical teams to gather the documentation and information still missing.

Updated design control records, including risk management files, verification and validation protocols, and design input/output traceability, so the records matched regulatory expectations.

Put change control in place that held when product designs or documentation changed.

Built remediation plans that closed deficiencies against the deadlines already on the calendar.

Prepared DHF documentation for audit and inspection.

Outcome

The client updated its DHFs ahead of the EU MDR deadline.

Regulatory requirements were met, and the products stayed on the European market without interruption.

Design control processes were clearer and easier to maintain going forward.

The work met the immediate compliance deadline and left the client's quality systems in better shape than before the remediation started.