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Medical Device PCBA – Certified Printed Circuit Board Assembly for Diagnostic, Monitoring & Therapeutic Equipment
No.YQQX010
- Strict Medical Compliance – Manufactured Under ISO 13485:2016 Certified Quality Management System; Fully Compliant with IEC 60601 Safety Standards and FDA 21 CFR Part 820 Design Controls.
- High-Reliability Assembly – Medical-Grade Component Sourcing (Authorized Distributors Only), 100% AOI + X‑ray Inspection (for BGA), and Conformal Coating for Protection Against Moisture, Dust, and Chemicals.
- Full Turnkey Service – From PCB Fabrication, Component Procurement, SMT/THT Assembly, to Functional Testing and Accelerated Aging – One‑Stop Solution for Class II & III Medical Devices.
- Complete Traceability – Individual Component Traceability with Batch/Lot Codes; Full Documentation Package (BOM, Assembly Drawings, Test Reports) for Regulatory Audits.
- Customizable for Various Applications – Supports Rigid, Flexible, Rigid‑Flex PCBs (2–16 Layers), High‑TG, Metal‑Core, and HDI Designs; Suitable for Patient Monitors, Infusion Pumps, Ventilators, Imaging Systems, and Lab Instruments.
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Product Overview
The Medical Device PCBA is a high‑reliability printed circuit board assembly specifically engineered for diagnostic, monitoring, and therapeutic medical equipment. From design verification to mass production, every step follows stringent medical industry standards (ISO 13485, IEC 60601, FDA QSR) to ensure patient safety, device dependability, and regulatory readiness.
Contact us to discuss your medical device PCBA requirements – from concept to clinical‑ready product.
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