ISO 13485 Medical IC PCBA Assembly with Full Traceability Service EMS

Name: ISO 13485 Medical IC PCBA Assembly with Full Traceability Service EMS
Brand: Primustron Electronics
SKU: 2149190732

Beijing, ChinaPrimustron Electronics

US$1.00-3.00

1 Piece

Product profile

Customization

Available

Conductive Type

Bipolar Integrated Circuit

Integration

GSI

Model NO.

001

Operating Temperature

0℃ - 70℃

Shape

DIP

Technics

Semiconductor IC

Transport Package

ESD Bag, Carton Box

Specification

Customized

Trademark

Customized

Origin

China

Key features

ISO 13485 Medical Certification: Certified for medical grade PCBA assembly with strict quality standards.

Full Traceability Service: Complete barcode and MES traceability for components, processes, and operators.

High Production Capacity: 30 million SMT points and 100,000 DIP pieces daily with scalable capacity.

Turnkey Assembly Solution: End-to-end services from design, sourcing, assembly to packaging and testing.

No MOQ Restriction: Supports both prototype and mass production without minimum order limits.

Comprehensive Testing: Includes 3D SPI, AOI, X-ray, ICT, FCT, and burn-in testing.

Global Logistics Support: Flexible delivery terms (FOB, CIF, EXW) and multiple payment methods.

Company profile

Standardized quality controlR&D CapabilitiesRaw-Materials TraceabilityOEM Services

Primustron Electronics

Beijing, China

Business Type: Manufacturer/Factory, Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc.Average Response Time: ≤1.98h

AI-Powered supplier vetting

SummaryThe supplier appears to be an electronics and medical-device-related manufacturer with SMT, THT, coating, and functional testing facilities, seven production lines, and stated PCBA and wire-and-cable output. It supports extensive customization and reports OEM service for known brands. Quality systems are supported by multiple certifications, including ISO 9001, ISO 14001, ISO 45001, ISO 13485, IATF-16949, and IECQ QC 080000. Service procedures exist for corrective actions, customer complaints, and finished-product inspection. However, the supplier has no valid manufacturing-capacity contract with affiliated subcontractors, no overseas warehouse, showroom, agents, or branches, and reports no overseas-service countries. Financial credibility cannot be established because the provided recent financial indicators are all zero. Innovation evidence is limited: one R&D engineer is reported and no SDK is available. Customer-case evidence is limited to a general statement of OEM service for known brands.

Supplier typeThe supplier operates manufacturing facilities for SMT, THT, coating, and functional testing, with seven production lines and stated PCBA and wire-and-cable output. Its business scope includes electronic products and Class I/Class II medical-device-related activities, indicating an electronics manufacturer with medical-device-related business coverage.

CertificationsThe supplier reports ISO 9001:2015, ISO 14001:2015, ISO 45001, ISO 13485:2016, IATF-16949, and IECQ QC 080000 certifications, alongside stated quality assurance in quality-control processes. These certifications provide explicit evidence of formal quality, environmental, occupational-safety, medical-device, automotive, and hazardous-substance management systems.

After-Sales capabilityThe supplier has documented and followed procedures for corrective and preventive actions, customer complaints, and finished-product inspection. It has inventory capability and accepts FOB, CIF, CFR, and EXW quotation terms, but lacks overseas warehouses, showrooms, agents, branches, and stated overseas-service coverage.

Production capacityThe supplier reports seven production lines, SMT/THT/coating/function-testing facilities, uniform finished-product inspection instructions, inventory capability, stated PCBA and wire-and-cable output, and peak-season fulfillment within 15 workdays. A deficiency remains because there is no valid manufacturing-capacity contract with affiliated subcontractors.

Customization capabilityThe supplier explicitly supports customization from samples and designs, full and minor customization, and flexible customization. It also reports OEM service for known brands, providing direct evidence of substantial customization and contract-manufacturing capability.

Product Q&A

Q:What types of products are your PCBA services primarily targeted at?

Medical devices, automotive electronics, rail transit, industrial products, new energy products, network communication products, instruments and meters, products with high process complexity, and more.

Q:What information is required for a PCBA quote?

PCB details, bill of materials (BOM), and test documents.

Q:What is your minimum order quantity (MOQ)?

There is no MOQ restriction. We support both prototype and volume production.

Q:Do you ensure confidentiality for suppliers' product information and design files?

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.

Q:What services can you provide?

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.