Design History Files Through Post-Market Surveillance
Complete design control documentation from concept through commercial distribution. Maintain traceability across every phase of the medical device lifecycle.
What Medical Device Teams Deal With Every Day
Design History File Management
FDA requires a complete Design History File for every medical device. Managing DHFs across documents, spreadsheets, and email chains creates compliance gaps.
Design Control Traceability
Tracing design inputs to outputs, verification to validation, and requirements to test results must be seamless. Disconnected systems break the traceability matrix.
Post-Market Surveillance Documentation
Complaint handling, CAPA management, and post-market clinical follow-up all generate documentation that must be linked back to design records.
Multi-Standard Compliance
FDA QSR, ISO 13485, EU MDR, and IEC 62304 each have overlapping but distinct documentation requirements. Manual compliance management is unsustainable.
Built for Medical Device Workflows
Design History File Management
Complete DHF management in one platform — design inputs, outputs, reviews, verification, validation, and design transfer. Every document linked, versioned, and audit-ready.
- Structured DHF templates per FDA guidance
- Design input/output linking and traceability
- Design review documentation with electronic signatures
- Design transfer records and production readiness
Design Control Traceability
Build and maintain your traceability matrix within the ELN Suite. Link requirements to design outputs, verification protocols to test results, and risks to mitigations.
- Requirements traceability matrix management
- Verification and validation protocol templates
- Test result linking to design specifications
- Risk management integration (ISO 14971)
FDA QSR & ISO 13485 Compliance
Built-in workflows for both FDA Quality System Regulation and ISO 13485 requirements. Automated audit trails, CAPA management, and controlled document workflows.
- FDA 21 CFR Part 820 compliance workflows
- ISO 13485 quality management documentation
- CAPA tracking with root cause analysis
- Management review and quality objective tracking
Post-Market Surveillance
Document complaint investigations, adverse event reports, and post-market clinical follow-up. Link surveillance findings back to design records for continuous improvement.
- Complaint handling and investigation tracking
- Adverse event and MDR reporting documentation
- Post-market clinical follow-up records
- Trend analysis and signal detection
Controlled Document Management
SOPs, work instructions, and specifications managed with formal review and approval workflows. Version control, change management, and distribution tracking built in.
- Formal document review and approval workflows
- Version control with complete change history
- Change management with impact assessment
- Training records linked to document revisions
Regulations We Cover
Not generic “we support compliance” — specific, deep regulatory coverage.
FDA 21 CFR Part 820
Quality System Regulation for medical device design, manufacturing, and distribution
ISO 13485
Quality management systems for medical devices — regulatory requirements
EU MDR 2017/745
European Medical Device Regulation for CE marking and market access
ISO 14971
Application of risk management to medical devices
IEC 62304
Medical device software lifecycle process requirements
FDA 21 CFR Part 11
Electronic records and signatures for regulated medical device documentation
See How ELN Suite Fits Your Medical Device Team
Schedule a demo tailored to medical device workflows — design controls, DHF management, and post-market surveillance.
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