Medical Device Design History File & Technical File Creation

RookQS’ team of experienced, certified Quality Engineers will help to create and maintain your medical device Design History File and/or Technical File to ensure compliant design control, risk management, design transfer, and manufacturing oversight per 21 CFR 820.30.

What is a Design History File?

A DHF/TF is a document that demonstrates  to the FDA that your medical device was developed in compliance with their regulations and applicable standards and according to the project’s approved design plan. A well organized DHF/TF creates traceability through the device’s design history that lowers the burden during an audit or inspection. The DHF/TF is helpful in the change control process by identifying related requirements and documents that may be affected by a proposed design or process change. Establishing the DHF/TF also preserves design-related information within the business and ensures that accurate and up-to-date information on the design is passed around to employees.

What is a Design History File Used For?

A Medical Device Design History File (DHF) is a critical document used in medical devices’ development and regulatory compliance process. The primary purposes of a DHF are:

Regulatory compliance: Demonstrates adherence to regulations and guidelines for safety and effectiveness.

Traceability: Provides a record of the entire design and development process, allowing for issue identification and resolution.

Design control: Ensures the device meets its intended use, user needs, and design requirements through a systematic approach.

Quality management: Supports adherence to quality standards and consistency in the design process.

Audits and inspections: Serves as a reference during regulatory audits to showcase a compliant design and development process.

Post-market surveillance and risk management: Supports tracking of device performance, risk management, and identifying areas for improvement or potential recalls.

A Design History File shows that a medical device meets regulations, safety standards, and quality standards.

What is included in a Design History File?

A Design History File typically contains records that provide details about a medical device’s design and development process, such as design specifications and manufacturing processes.

1. Design and development planning
2. User needs and design inputs
3. Design outputs
4. Design verification
5. Design validation
6. Design reviews
7. Design transfer
8. Design changes
9. Risk management
10. Clinical evaluations or testing
11. Regulatory submissions and approvals

These records facilitate regulatory compliance, trackability, and quality management through the device’s life cycle.

Rook Quality Systems Can Help you With your Design History & Technical Files

RookQS can also provide expert guidance regarding how and when to conduct your first hazard analysis. We can walk you through creating both your DHF/TF and your Risk Management File (RMF) in parallel. This idea of risk-based design incorporating risk analysis and risk management is found in many ISO and IEC standards. This approach can be a tool used to reduce the time and costs of repeated design iterations that may be required when risk is assessed late in the design process.

Our custom templates for the Design History File/Technical File and Risk Management File have been through many audits and inspections, and can help your company through every step of the certification process.