Design Transfer Report
Summary
A Design Transfer Report documents the completion and results of design transfer activities, providing evidence that your medical device design has been successfully transferred from development to manufacturing. This report demonstrates that manufacturing processes can consistently produce devices conforming to validated design specifications and regulatory requirements.
Why is Design Transfer Report important?
The Design Transfer Report serves as critical documentation proving that your manufacturing process accurately reflects the validated design and can consistently produce compliant medical devices. Regulatory authorities require this evidence to verify that design controls were properly maintained during the transition to manufacturing. Without a comprehensive transfer report, you cannot demonstrate that manufactured devices will perform as intended or meet the safety and effectiveness requirements established during design validation.
Regulatory Context
Under 21 CFR Part 820 (Quality System Regulation):
- Design transfer documentation is required under Section 820.30(h)
- Must provide objective evidence that design outputs were correctly translated
- Transfer results must be documented and verified before commercial distribution
- Required for Design History File completeness (820.30)
- Must demonstrate manufacturing capability to produce conforming devices
Special attention required for:
- Complete verification of manufacturing process capability
- Documentation of all transfer verification activities
- Evidence of personnel training and qualification completion
- Integration with overall design control documentation
Under 21 CFR Part 820 (Quality System Regulation):
- Design transfer documentation is required under Section 820.30(h)
- Must provide objective evidence that design outputs were correctly translated
- Transfer results must be documented and verified before commercial distribution
- Required for Design History File completeness (820.30)
- Must demonstrate manufacturing capability to produce conforming devices
Special attention required for:
- Complete verification of manufacturing process capability
- Documentation of all transfer verification activities
- Evidence of personnel training and qualification completion
- Integration with overall design control documentation
Under EU MDR 2017/745:
- Transfer documentation must be part of technical documentation (Annex II, Section 3)
- Must demonstrate compliance with EN ISO 13485:2016 design transfer requirements
- Reports must be available for notified body assessment
- Must support declaration of conformity for manufacturing processes
Special attention required for:
- Risk management integration throughout transfer verification
- Post-market surveillance system readiness documentation
- Traceability system implementation verification
- Quality management system effectiveness demonstration
Guide
Your Design Transfer Report should comprehensively document the execution and results of design transfer activities, demonstrating successful transition from design to manufacturing.
Executive Summary and Transfer Overview
Transfer Objectives Achievement: Summarize how well the design transfer met its stated objectives including quality targets, timeline adherence, and success criteria fulfillment. Provide a clear assessment of transfer success and readiness for commercial manufacturing.
Scope Completion: Document the complete scope of design transfer activities including all design outputs transferred, manufacturing processes established, and quality systems implemented. Confirm that all planned transfer activities were completed successfully.
Key Accomplishments: Highlight major achievements during design transfer including process capability demonstrations, personnel qualifications, and system implementations. Emphasize critical milestones that support manufacturing readiness.
Transfer Activity Results Documentation
Manufacturing Setup Results: Document the results of manufacturing facility preparation, equipment installation and qualification, and infrastructure setup. Include evidence that manufacturing capabilities meet design requirements and regulatory standards.
Process Development Outcomes: Report the results of manufacturing process development including process optimization, capability studies, and control system implementation. Demonstrate that processes are capable of consistently producing conforming devices.
Personnel Training and Qualification: Document completion of all personnel training and qualification activities including competency assessments, certification records, and ongoing training plans. Confirm that manufacturing personnel are qualified to perform their assigned functions.
Verification and Validation Results
Transfer Verification Evidence: Present comprehensive results of design transfer verification activities including first article inspection results, process capability studies, and comparative testing with development units. Demonstrate that manufacturing processes produce devices conforming to design specifications.
Manufacturing Validation Summary: Summarize manufacturing validation results including process capability indices, statistical control evidence, and acceptance criteria achievement. Reference detailed validation reports and confirm manufacturing readiness.
Design Verification Maintenance: Document confirmation that manufacturing processes maintain all design verification results including performance, safety, and regulatory compliance verification. Demonstrate continuity between design validation and manufacturing capability.
Quality System Implementation
Quality Control System: Document implementation of quality control procedures including inspection requirements, test procedures, statistical process control, and corrective action systems. Demonstrate effective quality oversight of manufacturing operations.
Documentation and Records: Confirm implementation of documentation control systems including manufacturing procedures, work instructions, batch records, and quality records. Demonstrate traceability and control of manufacturing documentation.
Change Control Integration: Document integration of manufacturing processes with change control procedures including change evaluation criteria, approval processes, and impact assessment procedures. Establish clear boundaries for manufacturing changes.
Risk Management and Compliance
Risk Control Implementation: Document implementation of risk controls in manufacturing processes including design controls, process controls, and quality controls. Demonstrate that manufacturing maintains risk control effectiveness established during design.
Regulatory Compliance Verification: Confirm that manufacturing processes comply with applicable regulatory requirements including quality system regulations, device-specific standards, and labeling requirements. Document compliance verification activities and results.
Post-Market Surveillance Readiness: Document manufacturing system readiness to support post-market surveillance activities including complaint handling, adverse event reporting, and corrective action implementation. Establish clear interfaces between manufacturing and post-market activities.
Example
Scenario
You have completed design transfer for your mobile cardiac monitoring application to your software development and distribution partner. The transfer included establishing automated build processes, quality control procedures, and distribution systems. You need to document the transfer results and confirm readiness for commercial software manufacturing.
Design Transfer Report
1. Executive Summary This report documents the successful completion of design transfer for the CardioMonitor mobile application (Version 2.1.0) to CloudTech Software Solutions. All transfer objectives were achieved, and the manufacturing process is ready for commercial production. Transfer activities were completed on schedule with all acceptance criteria met.
2. Transfer Scope and Completion The design transfer encompassed:
- Automated software build and compilation system establishment
- Quality assurance and testing procedure implementation
- Digital signing and security control setup
- Distribution and deployment system configuration
- Personnel training and qualification completion
All planned activities were completed successfully with documented evidence of compliance with design specifications and regulatory requirements.
3. Manufacturing Process Verification Results
Build Process Capability:
- Process capability index (Cpk): 4.57 (target: ≥ 1.33)
- Build success rate: 100% over 15 verification builds
- Average build time: 24.1 minutes (specification: ≤ 30 minutes)
- Automated test pass rate: 100% (1,247 tests per build)
Quality Control Implementation:
- All quality control procedures implemented and verified
- Statistical process control system operational
- Automated quality gates functioning correctly
- Non-conformance handling procedures established
Security Control Verification:
- Digital signing process validated with 100% success rate
- Certificate management procedures implemented
- Cybersecurity controls verified and operational
- Data protection measures confirmed compliant
4. Personnel Qualification Results All manufacturing personnel completed required training and demonstrated competency:
- Software build engineers: 3 personnel qualified
- Quality assurance specialists: 2 personnel qualified
- Release management team: 2 personnel qualified
- Cybersecurity specialist: 1 personnel qualified
Competency assessments documented 100% pass rate with all personnel demonstrating proficiency in assigned responsibilities.
5. First Article Verification Three first article software builds were produced and verified:
- All builds passed complete verification testing
- Functional performance matched design validation results
- Security controls operated as specified
- Distribution packages met all quality requirements
- User interface and functionality identical to validated design
6. Risk Control Implementation All design risk controls successfully implemented in manufacturing:
- Automated testing prevents release of defective software
- Digital signing ensures software integrity and authenticity
- Version control prevents unauthorized software modifications
- Access controls limit manufacturing system access to qualified personnel
7. Regulatory Compliance Confirmation Manufacturing processes comply with all applicable requirements:
- FDA 21 CFR Part 820 design control requirements
- EU MDR quality management system requirements
- Cybersecurity framework implementation
- Software lifecycle process compliance
8. Commercial Manufacturing Authorization Based on successful completion of all design transfer activities and achievement of all acceptance criteria, the CardioMonitor software manufacturing process is authorized for commercial production effective immediately. Ongoing monitoring and periodic review procedures are established to maintain manufacturing capability.