DHF
DHF (Design History File) is a required collection of documents that shows how a medical device was designed and developed. Think of it as a detailed diary that tracks every decision and step taken while creating a medical product. Companies must maintain DHFs to prove to regulators like the FDA that they followed proper procedures when designing medical devices. This is similar to having a complete recipe book that not only lists ingredients but explains why each ingredient was chosen and how the recipe was developed. Related terms you might see include "Design Controls" or "Product Development Documentation."
Examples in Resumes
Created and maintained DHF documentation for Class II medical devices
Led team responsible for Design History File compliance
Managed multiple DHF projects through FDA approval process
Typical job title: "Quality Engineers"
Also try searching for:
Where to Find Quality Engineers
Professional Organizations
Online Communities
Job Resources
Example Interview Questions
Senior Level Questions
Q: How would you handle a situation where DHF documentation is found to be incomplete during an FDA audit?
Expected Answer: A senior professional should discuss creating an action plan, implementing corrective actions, conducting thorough document review, and establishing preventive measures for future compliance.
Q: Describe your experience in improving a DHF system.
Expected Answer: Should explain experience in streamlining documentation processes, implementing electronic systems, training teams, and ensuring compliance while making the system more efficient.
Mid Level Questions
Q: What are the essential components of a DHF?
Expected Answer: Should mention design inputs, outputs, verification, validation, reviews, and transfer documents, explaining how each contributes to the product development story.
Q: How do you ensure DHF documentation stays current throughout product development?
Expected Answer: Should discuss document control procedures, change management processes, and regular review practices.
Junior Level Questions
Q: What is the purpose of a DHF?
Expected Answer: Should explain that DHF documents the complete history of a medical device's design process for regulatory compliance and quality assurance.
Q: How do you organize documents within a DHF?
Expected Answer: Should describe basic file organization, document numbering systems, and the importance of maintaining a clear structure for easy retrieval.
Experience Level Indicators
Junior (0-2 years)
- Basic understanding of FDA regulations
- Document control basics
- Quality system fundamentals
- Basic DHF filing and organization
Mid (2-5 years)
- DHF review and maintenance
- Design control implementation
- Quality system management
- Regulatory submission preparation
Senior (5+ years)
- FDA audit management
- Quality system optimization
- Team training and leadership
- Design control program development
Red Flags to Watch For
- No knowledge of FDA regulations or quality system requirements
- Lack of attention to detail in documentation
- No experience with design controls
- Unable to explain basic documentation practices
Related Terms
Need more hiring wisdom? Check these out...
Cutting HR Costs Without Sacrificing Quality: A How-To for Savvy Executives
How to align the HR strategy with the companys long-term business objectives
Human Capital Operational Excellence: Unlocking Your Organization's Potential
