Case Study: DHF Remediation Support for Class I Medical Devices

Case Study: DHF Remediation Support for Class I Medical Devices

Challenge:
A client approached Viltis with an urgent need for Design History File (DHF) remediation for their Class I medical devices. Due to changes in the European Medical Device Regulation (EUMDR), the client was required to update their DHFs to ensure compliance and maintain market access in Europe. With strict deadlines looming, it was critical to deliver a solution that ensured regulatory compliance while minimizing disruptions to their operations.

Solution:
Viltis quickly deployed a specialized team of Quality Engineers to collaborate closely with the client’s quality and regulatory teams. These experts brought deep knowledge of medical device development processes and regulatory requirements, including EUMDR, IVDR, FDA 21 CFR Part 820, and ISO 13485.

Our team followed a structured approach:

• Conducted a comprehensive review of existing DHFs to identify compliance gaps.
• Collaborated cross-functionally with R&D, Quality Assurance, Regulatory Affairs, and Clinical teams to gather required documentation and information.
• Updated critical design control documents, including risk management files, verification and validation protocols, and design input/output traceability, ensuring all records aligned with regulatory standards.
• Implemented robust change control processes to uphold compliance when changes were made to product designs or documentation.
• Developed and executed remediation plans that addressed deficiencies while meeting aggressive deadlines.
• Provided audit-readiness support by ensuring all DHF documentation was compliant and inspection-ready.

Results:
Thanks to Viltis' expertise and hands-on approach:

• The client successfully updated their DHFs ahead of the EUMDR deadline.
• All regulatory requirements were met, enabling the client to continue selling their products in Europe without interruption.
• The client’s design control processes were significantly improved, establishing a robust framework for future regulatory compliance.

Impact:
This project not only addressed immediate compliance needs but also positioned the client for long-term success by strengthening their quality systems. By delivering tailored solutions and assembling a team with the right expertise, Viltis demonstrated its commitment to excellence and regulatory integrity.