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ISO13485 Medical PCBA Turnkey EMS Assembly with RoHS Compliance

Name: ISO13485 Medical PCBA Turnkey EMS Assembly with RoHS Compliance
Brand: Primustron Electronics
SKU: 2168035062

Beijing, ChinaPrimustron Electronics

US$0.01-3.00

1 Piece

Product profile

Customization

Available

Metal Coating

Copper

Mode of Production

SMT

Model NO.

001

Layers

Multilayer

Base Material

FR-4

Certification

RoHS, CCC, ISO

Customized

Condition

New

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

Product Name

Industrial Equipment PCBA

Placement Precision

±0.03mm / ±0.01mm (Chip)

Transport Package

ESD Bag, Carton Box

Specification

Customized

Trademark

Customized

Origin

China

Key features

Medical Grade Certification: ISO 13485:2016 certified for high-reliability medical device PCBA assembly.

Scalable Production Capacity: SMT capacity of 30 million points/day and DIP capacity of 100,000 pieces/day.

Comprehensive Turnkey Service: End-to-end solutions from design, sourcing, assembly to box building and testing.

Advanced Testing Capabilities: Includes 3D SPI, 3D AOI, X-ray, Flying Probe, ICT, FCT, and Burn-in tests.

No Minimum Order Quantity: Supports both prototype and mass production without MOQ restrictions.

Strict Confidentiality: NDA compliance available to protect customer design files and product data.

Fast Lead Time: Prototypes delivered in 5-10 days; Mass production in 15-25 working days.

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: ≤0.53h

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?

We provide turnkey services including PCB design, FAB, component sourcing, PCBA assembly, box building, packaging, BOM analysis, conformal coating, IC programming, and wire harness assembly.