Design History File (DHF) Services
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.
Design History File Consulting
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
RCA can provide needed Medical Device remediation expertise and services in the following key areas:
- Remediation Services
- Technical File and Design History File (DHF)
- Regulatory Action
- 21 CFR Part 11 & Computerized System Validation
To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].
