Regulatory Compliance Associates® Inc. provides program oversight and resources to assist with remediation activities for technical file inadequacies or legacy Design History Files (DHFs). 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 DHF-related support services include:


  • Risk Management: Use, Design, and Process
  • Sterilization Validation
  • Design Validation Testing
  • Essential Requirements Checklist
  • Product Specifications
  • Design Verification Testing
  • Shelf Life Testing: Product and Package
  • Process Validation

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