Custom ISO 13485 Medical PCBA Turnkey EMS Solutions RoHS & Reach Compliant

Name: Custom ISO 13485 Medical PCBA Turnkey EMS Solutions RoHS & Reach Compliant
Brand: Primustron Electronics
SKU: 2141965032

Beijing, ChinaPrimustron Electronics

US$1.00-5.00

1 Piece

Product profile

Customization

Available

Metal Coating

Copper

Mode of Production

SMT

Model NO.

Medical PCBA

Layers

Multilayer

Base Material

FR-4

Certification

RoHS, CCC, ISO

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

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: ≤0.33h

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.