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A comprehensive compilation of records that describes the design history of a finished medical device, required by FDA regulations.
A Design History File (DHF) is a regulatory requirement that serves as the master documentation repository for medical device development, containing all records that describe how a device was designed, tested, and approved for market release.
When developing medical devices, your team likely captures critical design decisions, test results, and development processes in various formats, including video recordings of design reviews and testing procedures. These videos become valuable components of your Design History File (DHF), but they present challenges for FDA compliance and accessibility.
Video recordings of design validation sessions or risk analysis meetings may contain essential DHF information, but they're difficult to reference during audits or when onboarding new team members. Searching for specific design decisions within hours of video footage can delay regulatory submissions and create compliance risks for your Design History File.
Converting these video walkthroughs into structured SOPs transforms your Design History File management. By extracting key design controls information from videos into searchable documentation, you create an audit-ready DHF that regulatory bodies can easily review. This documentation approach ensures design history elements are consistently formatted, properly indexed, and accessible to all stakeholders—essential qualities when FDA inspectors request specific components of your Design History File during pre-market approval.
Medical device companies struggle to compile comprehensive documentation packages for 510(k) or PMA submissions, often missing critical design documentation or failing to demonstrate design control compliance.
Implement a structured DHF system that continuously captures all design activities and maintains regulatory-ready documentation throughout the development process.
1. Establish DHF template with all required sections per 21 CFR 820.30 2. Create design input specifications document 3. Document all design outputs including drawings and specifications 4. Conduct and record formal design reviews at each phase 5. Execute verification and validation protocols 6. Maintain change control records 7. Compile final DHF package with traceability matrix
Reduced submission preparation time by 60%, improved FDA response rates, and eliminated documentation gaps that previously caused regulatory delays.
When design changes occur during development, teams lack visibility into the full impact across all design documentation, leading to incomplete change assessments and potential compliance issues.
Utilize DHF structure to create comprehensive change control processes that track impacts across all design elements and maintain complete audit trails.
1. Document change request with rationale 2. Assess impact on design inputs and outputs 3. Review affected verification and validation activities 4. Update risk management documentation 5. Conduct design review of proposed changes 6. Execute additional testing if required 7. Update all affected DHF documents 8. Document change approval and implementation
Improved change control accuracy, reduced regulatory risk, and maintained complete traceability of design evolution throughout product lifecycle.
Large medical device development teams struggle with document coordination across engineering, regulatory, quality, and clinical teams, resulting in version control issues and communication gaps.
Establish centralized DHF repository with role-based access controls and collaborative review processes that ensure all stakeholders contribute to and access current design documentation.
1. Define team roles and DHF access permissions 2. Create collaborative document templates 3. Establish review and approval workflows 4. Implement automated notification systems 5. Set up regular cross-functional design reviews 6. Maintain centralized document repository 7. Track document status and pending actions
Enhanced team coordination, reduced documentation errors, improved design review quality, and faster decision-making across all development phases.
When post-market issues arise, companies need to quickly access design rationale and testing data to assess product safety and determine corrective actions, but this information is scattered across multiple systems.
Maintain comprehensive DHF that provides immediate access to design decisions, test data, and risk assessments to support rapid post-market issue investigation and response.
1. Ensure DHF includes complete design rationale documentation 2. Link risk management records to design decisions 3. Maintain verification and validation test data 4. Document known limitations and contraindications 5. Create searchable index of design elements 6. Establish rapid access procedures for investigations 7. Train post-market teams on DHF navigation
Faster incident investigation response times, improved root cause analysis capabilities, and more effective corrective and preventive action (CAPA) implementation.
Create the complete DHF framework and document templates before beginning design activities to ensure consistent documentation capture throughout the entire development process.
Keep DHF documents current with design activities rather than allowing documentation to lag behind development work, ensuring accuracy and preventing information loss.
Create clear linkages between design inputs, outputs, verification activities, and validation results to demonstrate complete design control compliance and facilitate impact assessments.
Perform periodic assessments of DHF completeness and quality to identify gaps, inconsistencies, or missing documentation before they become compliance issues.
Create consistent formats and requirements for design review records to ensure all reviews meet regulatory requirements and provide clear evidence of design control activities.
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