ISO 13485 Medical PCBA PCB Design & Fabrication SMT Assembly
Product Details
| Customization: | Available |
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| Metal Coating: | Copper |
| Mode of Production: | SMT |
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Basic Info.
- Model NO.
- Medical PCBA
- Layers
- Multilayer
- Base Material
- FR-4
- Certification
- RoHS, CCC, ISO
- Customized
- Customized
- Condition
- New
- Product Name
- Medical PCBA
- Service
- PCB+Assembly+Components
- Testing Service
- Electrical Testing, Flying Probe Tester, Functiona
- Value-Added Services
- Bom Analysis, Conformal Coating, IC Programming
- Technical Support
- Free Dfm/a Check, Bom Analysis
- Placement Precision
- ±0.03mm / ±0.01mm (Chip)
- Transport Package
- ESD Bag, Carton Box
- Specification
- Customized
- Trademark
- Customized
- Origin
- China
Packaging & Delivery
- Package Size
- 60.00cm * 60.00cm * 40.00cm
- Package Gross Weight
- 5.000kg
Product Description
Workshop Introduction
Product Description
Medical Device PCB Assembly PCBA
Specification
Turnkey Service | PCB Design + PCB FAB + Component Sourcing + PCBA + Box Building + Packaging |
Value-Added Services | BOM Analysis, Conformal Coating, IC Programming, Wire Harness & Cable Assembly |
Assembly Details | 15 SMT Lines + 4 DIP Lines; Dust-free & Anti-static Workshop |
Assembly Capacity | SMT: 30 Million points/day; DIP: 100,000 pieces/day (Scalable) |
Technical Support | DFX (DFM/DFA/DFT) Check, BOM Optimization, Alternative Component Suggestion |
Quality Standards | IPC-A-610 Class 2 / Class 3 (Medical Grade) |
Traceability | Full Barcode/MES Traceability (Component batch, Process, Operator) |
Inspection & Testing | 3D SPI + 3D AOI, X-ray, IQC/IPQC/FQC/OQC, Flying Probe, ICT, FCT, Burn-in Test |
Files Format | Gerber (RS-274-X), PCB, PCBDOC, BOM (Excel), Pick-and-Place File |
Solder Type | No-Clean / Water Soluble, RoHS Lead-Free, High-reliability Solder |
Assemble Methods | SMT, THT & Hybrid, Single/Double-sided, POP, BGA Repair/Reball |
Component Size | Passive: 0201 (01005 support); Fine-pitch BGA, QFN, CSP, WLCSP |
Minimum IC Pitch | 0.2mm (High Precision) |
Min. space of BGA | 0.3mm |
Placement Precision | ±0.03mm / ±0.01mm (Chip) |
Certifications | ISO 13485:2016 (Medical), IATF 16949, ISO 9001, UL, CE, RoHS |
Lead / Turn Time | Prototype: 5-10 working days; Mass Production: 15-25 working days |
Packaging | ESD Bag / Vacuum / Customized Medical Grade Packaging |
Products at a Glance
Company Profile
For over 20 years, Kunfang Electronics has dedicated itself to serving industries including medical devices, automotive electronics, new energy, rail transit, and many others. We provide end-to-end turnkey services, encompassing BOM sourcing (component procurement), product design solutions, SMT assembly, THT assembly, wire harness processing, conformal coating, box build assembly & testing, environmental stress screening, final packaging, and logistics delivery.
Kunfang Electronics is headquartered in Beijing and operates multiple production bases across the Beijing-Tianjin-Hebei region, covering a total area of approximately 28,000 square meters. Our facilities include a Class 10,000 cleanroom of around 10,000 square meters, dedicated RoHS-compliant workshops, and specialized lines for small-batch trial production. Our production base features world-class hardware, including Japanese YAMAHA high-speed mounters and Germany ERSA nitrogen reflow ovens. Additionally, we operate multiple fully automated lines for wire harness production, conformal coating and curing, as well as system assembly and testing.
Relying on superior product quality, Kunfang Electronics has empowered numerous industry leaders to become suppliers for national-level projects. We take immense pride in being a vital link in the supply chain, with our PCBA products successfully deployed in mission-critical applications such as the Tianzhou-2 cargo spacecraft, the Liaoning Aircraft Carrier, the Huoshenshan and Leishenshan hospitals, as well as high-speed rail and metro systems.
Relying on superior product quality, Kunfang Electronics has empowered numerous industry leaders to become suppliers for national-level projects. We take immense pride in being a vital link in the supply chain, with our PCBA products successfully deployed in mission-critical applications such as the Tianzhou-2 cargo spacecraft, the Liaoning Aircraft Carrier, the Huoshenshan and Leishenshan hospitals, as well as high-speed rail and metro systems.
Certificates
Packaging & Shipping
FAQ
Q1: What types of products are your PCBA services primarily targeted at?
A1: Medical devices, automotive electronics, rail transit, industrial products, new energy products, network communication products, instruments and meters, products with high process complexity, and more.
Q2: What information is required for a PCBA quote?
PCB details, bill of materials (BOM), and test documents.
A2: What is your minimum order quantity (MOQ)?
There is no MOQ restriction. We support both prototype and volume production.
Q3: Do you ensure confidentiality for suppliers' product information and design files?
A3: We are willing to sign a non-disclosure agreement (NDA) compliant with the customer's local laws and commit to maintaining strict confidentiality of all customer data.
Q3: What services can you provide?
A4: Accepted delivery terms: FOB, CIF, EXW, Express Delivery.
Accepted currencies: USD, CNY.
Accepted payment methods: L/C, T/T, D/P, Western Union, PayPal, MoneyGram.
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