Design History File

Regulatory Compliance Associates provides program oversight and resources to assist with remediation activities for technical file inadequacies or legacy Design History Files (DHF). From launching new products to updating design information to validate and maintain a device through its lifecycle, we have a thorough understanding of the requirements to ensure regulatory compliance.

Our technical file and Design History File related support services include:

• Design Input Analysis
• Design Output Analysis
• Development of Trace Matrices
• Risk Management: Use, Design, and Process
• Design Validation Testing
• Essential Requirements Checklist
• Product Specifications
• Design Verification Testing
• Process Validation