Medical Device Manufacturing System
Medical device manufacturers face strict regulatory requirements including FDA Quality System Regulation and ISO 13485. Sprint GMP provides the quality management and documentation systems needed to meet these requirements and ensure patient safety.
Medical Device Manufacturing Challenges
Medical device manufacturers must maintain rigorous quality systems, complete traceability, and detailed documentation. FDA inspections require access to device history records, quality control data, and complaint handling procedures. ISO 13485 certification demands systematic quality management with risk-based approaches.
Sprint GMP for Medical Device Manufacturing
Device History Records
FDA requires complete device history records showing all materials, processes, and quality control results for each device lot. Sprint GMP automatically creates batch records that serve as device history records, documenting every step from material receipt through final inspection.
FDA QSR Requirement: Maintain device history records for each batch or lot of devices.
Material Traceability
Medical devices require complete traceability of all materials and components. Sprint GMP tracks materials from supplier receipt through assembly to finished device, maintaining lot-level traceability. This enables rapid identification of devices affected by material issues.
Use Case: A component supplier reports a quality issue. You can instantly identify all device lots containing that component and take appropriate corrective action.
Quality Control Documentation
ISO 13485 requires documented quality control procedures and test records. Sprint GMP provides structured test records that link to specific device lots, store test results, and track approval status. All quality control data is searchable and ready for regulatory review.
ISO 13485 Requirement: Document quality control procedures and maintain test records.
Complaint and Adverse Event Management
Medical device manufacturers must systematically handle complaints and adverse events, with reporting requirements to FDA. Sprint GMP tracks complaints, links them to device lots, documents investigations, and maintains records required for FDA reporting. The system helps identify trends that may indicate device issues.
FDA Requirement: Establish procedures for complaint handling and adverse event reporting.
Corrective and Preventive Action
ISO 13485 requires systematic corrective and preventive action processes. Sprint GMP documents quality issues, tracks root cause analysis, records corrective actions, and monitors effectiveness. The system maintains a complete audit trail of all CAPA activities.
ISO 13485 Requirement: Establish procedures for corrective and preventive action.
Key Features for Medical Device Manufacturers
- Complete device history records
- Full material and component traceability
- Structured quality control test records
- Complaint and adverse event tracking
- Corrective and preventive action management
- Document management for quality system documentation
- Complete audit trail of all system changes
Meet Medical Device Requirements
Sprint GMP provides the quality management foundation for medical device manufacturing. Start your free trial to see how our system can help you meet FDA and ISO 13485 requirements.
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