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: ≤0.56h

AI-Powered supplier vetting

SummaryThe supplier is located at Tianshanguoji Industrial Quarter in Hebei and operates seven production lines. It holds several certifications, including ISO 9001 and ISO 13485, indicating strong quality management. The supplier offers extensive customization services and OEM for popular brands but lacks overseas warehouse and showroom capabilities. Its export percentage is low, and financial records suggest no recent revenue. Despite a capacity for stock management, the absence of a valid manufacturing contract is a concern.

CertificationsThe supplier holds multiple certifications such as ISO 9001, ISO 14001, ISO 13485, and IATF-16949, indicating robust quality and environmental management systems.

After-Sales capabilityThe supplier has a clear procedure for handling customer complaints and corrective actions, which suggests a structured approach to after-sales service.

Financial creditThe supplier's financial records show no operating revenue or profit in recent years, indicating potential issues with financial stability.

R&D capabilityWith only one R&D engineer and no SDK availability, the supplier's innovation capability appears limited.

Production capacityThe supplier operates seven production lines and has a significant production output, although primarily for the domestic market.

Customization capabilityThe supplier offers a wide range of customization options including full and minor customization, indicating strong customization capability.

Client casesThe supplier provides OEM services for well-known brands, indicating experience with significant customer cases.

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.