Design History File (DHF) Compilation

Organizing Compliance and Documentation for Your Medical Device

ADBC CRO provides expert services in Design History File (DHF) compilation, ensuring that your medical device development is thoroughly documented and compliant with FDA and international standards.

The Design History File (DHF) is a critical document that tracks the design and development of a medical device from inception to final production. It serves as evidence that your product meets regulatory requirements and is critical for FDA submissions and audits. At ADBC CRO, we specialize in compiling and managing comprehensive DHFs, thereby ensuring that every step of the design and development process is diligently documented and compliant with FDA 21 CFR Part 820, ISO 13485, and other applicable standards.

Why ADBC CRO is Your Ideal Partner for DHF Compilation

We can support the compilation of a comprehensive Design History File from end to end, ensuring all the documents required are captured and organized to meet FDA and ISO compliance.
  • Efficient Workflow for Efficiency
    Our process eliminates the complexity of creating a DHF, and a clear, organized file will reduce development time and make audits much easier.
  • Customized for Your Device
    ADBC CRO approaches this in a tailored manner so that the DHF reflects the unique design, risk management strategies, and regulatory pathway of your device.
  • Risk and Quality Management Integration
    We integrate risk assessments, validation reports, and design changes into the DHF so that all aspects of the device safety and effectiveness are completely documented.
  • Audit-Ready and Submission-Ready DHF
    Our DHF compilation services make sure your documentation is ready for smooth regulatory audits and quick market approval.

Our DHF Compilation Services Include

Comprehensive Documentation Management Organization and maintenance of all documents that pertain to design inputs, outputs, risk analysis, and validation to ensure full compliance.
Design Input and Output Documentation Gathering of detailed design inputs and outputs such as specifications, performance criteria, and design validation testing.
Risk Management File Integration Risk management documents like risk assessments and mitigation strategies are to be integrated within the DHF.
Verification and Validation Reports Ensure that the DHF comprises necessary reports that verify and validate the effectiveness and safety of the design.
Design Change Control Management and documentation of design change, which is to be extensively reviewed and ensures it complies with regulatory requirements.
Alignment with Regulatory Requirements Having your DHF compliant with all FDA, ISO 13485, and global regulations, which can easily breeze through future audits and submissions.
Audit-Ready DHF Creating a full-fledged and organized DHF that will stand against the strict scrutiny of regulatory inspections, audits, and evaluation.

Ensure accurate, compliant DHF with ADB CCRO’s expertise!

Contact Now

Global Impact

Our mission extends beyond delivering products and services; we are dedicated to making a lasting positive impact across the globe. Through our commitment to excellence in customer service, product innovation, and regulatory compliance, we drive sustainable growth, foster trust, and set new standards within our industry. Each initiative is part of our vision to empower communities, support industries, and contribute meaningfully to a better world.

0 +

Customer Served

0 +

Product Launched

0 +

Regulatory Submissions