Olive operates a documented medical device quality management system aligned with ISO 13485 and applicable MDSAP audit requirements.
From supplier qualification and incoming inspection to manufacturing, testing, final release, and packaging, each stage is managed through defined quality procedures. This supports consistent production, product traceability, and regulatory documentation for different markets.
Key Component Quality Control
Medical-Grade Molecular Sieves
Support consistent oxygen concentration and stable PSA performance during continuous operation.
Saint-Gobain Piston Cup Seals
Wear-resistant seals selected to support efficient compression and reliable oil-free operation.
Dual-Stage Filtration System
HEPA and GVS filtration help reduce particles and contaminants within the air and oxygen pathways.
Every oxygen concentrator is inspected throughout production and tested before shipment. From incoming components to final product release, our quality-control process is designed to identify potential defects, verify operating performance, and support consistent product quality.
Incoming Component Inspection
✓ Verify the specifications and quality of key components before production.
✓Check appearance, dimensions, materials, and basic operating performance.
✓ Record supplier and batch information for component traceability.
Assembly Control
✓ Inspect gas-path connections, electrical wiring, and component installation. ✓ Check sealing performance to help prevent air leakage and unstable output. ✓ Review assembly workmanship at key stages of the production process.
48-Hour Aging Test
✓ Run each oxygen concentrator continuously for 48 hours before final testing. ✓ Monitor oxygen concentration, flow rate, pressure, temperature, and noise. ✓ Verify operating stability and identify potential early-stage failures.
Final Testing
✓ Confirm oxygen concentration, flow accuracy, alarms, and safety functions. ✓ Inspect the machine’s appearance, accessories, labels, and packaging condition. ✓ Approve only qualified units for warehouse entry and final shipment.
Olive optimizes key gas-path and oxygen-generation components to support stable oxygen output, durable operation, and lower long-term maintenance requirements.
