solutions
Medical Device DHF Assessment
In the medical device industry, maintaining a thorough and compliant Design History File (DHF) is crucial for demonstrating that a device has been designed according to regulatory requirements and industry standards. The DHF serves as a comprehensive record of the design process, documenting every stage of development from initial concept to final design validation. Qualified Data Systems (QDS) offers a specialized DHF Assessment Solution designed to help medical device manufacturers ensure their DHFs are complete, accurate, and fully compliant with regulatory expectations. Our solution provides a detailed evaluation of your DHF, identifies gaps, and offers recommendations to strengthen your documentation and streamline regulatory submissions.
Solution Activities
Comprehensive DHF Review and Gap Analysis
- DHF Content Assessment: QDS conducts a thorough review of your DHF to ensure that all required documentation is present and meets regulatory requirements. We evaluate design inputs, design outputs, design verification and validation, risk management files, and other essential components.
- Gap Analysis and Remediation Plan: We perform a detailed gap analysis to identify any missing or incomplete documentation within your DHF. QDS provides a remediation plan with actionable recommendations to address these gaps, ensuring that your DHF is complete and compliant.
- Alignment with Regulatory Standards: Our assessment ensures that your DHF aligns with key regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and IEC 62366. We verify that your documentation meets the specific requirements for medical device design controls, usability engineering, and risk management.
Design Control Compliance
- Design Control Process Evaluation: QDS evaluates your design control processes to ensure they are properly documented and compliant with regulatory standards. This includes reviewing design planning, design input and output documentation, design review records, and change control procedures.
- Risk Management Integration: We assess the integration of risk management activities within your DHF, ensuring that risk analysis, risk evaluation, and risk control measures are well-documented and aligned with ISO 14971. Our assessment ensures that your risk management activities are traceable throughout the design process.
- Verification and Validation Documentation: QDS reviews your design verification and validation (V&V) documentation to ensure it adequately demonstrates that the design meets specified requirements. We assess the completeness of V&V protocols, test reports, and traceability matrices, ensuring that they support regulatory submissions.
Usability Engineering and Human Factors Analysis
- Usability Engineering File Review: QDS assesses the usability engineering file within your DHF to ensure it complies with IEC 62366 requirements. We review human factors studies, usability testing reports, and risk assessments related to user interaction with the device.
- Human Factors Validation: We evaluate the human factors validation process to ensure that it effectively identifies and mitigates potential use-related risks. QDS provides recommendations to enhance the usability engineering process, ensuring that user needs and safety considerations are fully addressed.
Regulatory Submission Support
- Pre-Submission DHF Assessment: QDS offers pre-submission assessments of your DHF to ensure it is ready for regulatory review. We identify any potential issues that could delay approval and provide recommendations for addressing them before submission.
- Regulatory Documentation Preparation: We assist in preparing the necessary documentation for regulatory submissions, including summary reports, technical files, and design dossiers. QDS ensures that your DHF is presented in a clear and organized manner, facilitating a smoother regulatory review process.
- Audit Preparation and Support: QDS provides support during regulatory audits by helping you prepare your DHF for inspection. We assist in organizing documentation, preparing responses to auditor inquiries, and addressing any findings related to the DHF.
Training and Continuous Improvement
- DHF Best Practices Training: QDS offers training programs on DHF best practices to ensure that your team understands the regulatory requirements and maintains high standards in documentation. Our training covers design controls, risk management, usability engineering, and regulatory expectations.
- Continuous Improvement of DHF Processes: We help organizations implement continuous improvement programs to enhance DHF management processes. QDS provides guidance on implementing document control systems, standardizing documentation practices, and maintaining up-to-date DHF records.
Industry Focus
QDS specializes in providing DHF Assessment solutions for the following sectors within the medical device industry:
- Class I, II, and III Medical Devices: Supporting the development of a wide range of medical devices, from low-risk products to high-risk, life-sustaining devices, ensuring that DHFs meet the specific requirements for each classification.
- Combination Products: Ensuring that DHFs for combination products, which integrate drugs, biologics, and devices, are compliant with both device and pharmaceutical regulatory requirements.
- In Vitro Diagnostics (IVDs): Assisting in the development and maintenance of DHFs for IVD products, ensuring compliance with regulatory requirements for diagnostic devices.
Value Proposition
QDS’s DHF Assessment Solution offers the following benefits:
Our solution ensures that your DHF meets all relevant regulatory requirements, reducing the risk of non-compliance and facilitating smoother regulatory approvals.
We provide a thorough evaluation of your DHF, identifying gaps and providing actionable recommendations to enhance documentation quality and completeness.
By ensuring that your DHF is complete and well-organized, we help streamline the regulatory submission process, reducing the likelihood of delays or rejections.
Our assessment strengthens your design control processes and risk management activities, ensuring they are effectively documented and integrated into your DHF.