Structured After-Sales Support for Long-Term OEM/ODM Programs
WAKELIFE provides structured after-sales support built on production traceability, documented processes, and manufacturing continuity—ensuring that red light therapy devices sustain lifecycle performance and maintain market compliance.
The Closed-Loop Resolution Framework
1.Issue Logged
Deviation recorded in QMS
2.Batch Traced
ERP & BOM data pulled
3.Root Cause Analyzed
8D Report & CAPA initiated
4.Process Updated
Manufacturing continuity secured
Traceability-Based Support
ERP & Batch Barcoding Integration
After-sales support is built upon structured production traceability. Every production run is linked to its original manufacturing data through our ERP system, including raw material lot numbers, process parameters, and quality control checkpoints. This enables batch-level investigation and ensures support actions are informed by actual production history.
By maintaining continuity between production and post-delivery support, WAKELIFE ensures that after-sales activities remain aligned with original manufacturing specifications.
- Full Batch History Record (DHR) access
- Component-level serialization
100%
Batch-level traceability maintained for all production runs
5+ Años
Production record retention for full lifecycle support
Issue Response & Analysis
ISO 13485 CAPA & 8D Methodology
When deviations occur, we apply structured analysis to identify underlying causes. Our investigation protocols strictly align with ISO 13485 CAPA (Corrective and Preventive Action) requirements and utilize 8D reporting. This approach ensures corrective actions contribute to long-term manufacturing consistency.
Corrective actions are permanently integrated into future production runs, moving beyond reactive fixes.
- 8D Problem Solving Methodology
- Regulatory compliance documentation
Manufacturing Continuity
BOM Locking & Process Standardization
Production continuity ensures that follow-up units, replacements, or subsequent batches remain aligned with established specifications. Through strict BOM (Bill of Materials) locking and process standardization, we maintain consistency between original production and future manufacturing.
Enabling OEM/ODM partners to continue their programs without disruption or specification drift.
- Strict Revision Control
- Change Control Board (CCB) oversight
Long-Term Partner Support
Sustain Lifecycle Performance
Our framework supports OEM/ODM programs throughout their entire lifecycle. Structured post-delivery processes, manufacturing continuity, and production traceability enable partners to sustain product consistency, ensuring devices maintain market compliance beyond initial delivery.
Supporting long-term collaboration built on engineering stability rather than short-term interventions.
- End-of-Life (EOL) planning
- Legacy component stockpiling
100%
Batch Traceability
ISO
13485 Aligned
5yr+
Record Retention
SLA
Defined Protocols
Ready to Secure Your Supply Chain?
Let’s discuss how our structured support framework aligns with your program requirements.
After-sales protocols are configured based on program scale, regulatory requirements, and specific OEM/ODM agreements.
