ISO 13485 Turnkey Service Medical Assembled PCBA

Name: ISO 13485 Turnkey Service Medical Assembled PCBA
Brand: Mu Star (shenzhen) Industry Co., Ltd.
SKU: 2104275665

Guangdong, ChinaMu Star (shenzhen) Industry Co., Ltd.

US$5.60

1-99 Pieces

US$5.20

100-999 Pieces

US$3.98

1,000-9,999 Pieces

US$2.68

10,000+ Pieces

Product profile

Customization

Available

Type

Rigid Circuit Board

Dielectric

FR-4

Model NO.

Mustar389

Material

Fiberglass Epoxy

Application

Medical Instruments

Flame Retardant Properties

Mechanical Rigid

Rigid

Processing Technology

Electrolytic Foil

Base Material

Copper

Insulation Materials

Organic Resin

Brand

Mustar

Copper Thickness

1-12 Oz

Board Thickness

0.8, 1.0, 1.2, 1.6, 2, 2.4mm

Surface Finishing

HASL,Immersion Gold,Flash Gold, Plated Silver, OSP

Minimum Line Spacing

0.015mm

Minimum Line Width Spacing

0.015mm

Testing Service

Ict, Function Test, X-ray, Aoi

MOQ

1PCS

Certificate

RoHS/ISO9001/Ts16949/ISO14001/ISO13485

Layers

1-64

Warranty

2 Years

Transport Package

Vacuum, Anti-Static, ESD

Specification

800*1200mm

Trademark

Mustar

Origin

Guangdong

HS Code

8504909090

Production Capacity

1000000PCS/Month

Key features

ISO 13485 Certified Medical PCBA: Fully compliant with ISO 13485 standards for medical instrument assembly.

Comprehensive Quality Testing: Includes X-ray, AOI, ICT, and 100% functional testing per IPC-A-610E.

24 Years Professional Experience: Expertise in PCB/FPC manufacturing, SMT, DIP, and component sourcing.

Flexible Customization Options: Customizable copper thickness, board thickness, surface finishing, and layers.

High Production Capacity: 16 SMT lines and 5 DIP lines with 700 million points/day capacity.

Low MOQ for Prototypes: Minimum Order Quantity is just 1 piece, ideal for samples and prototypes.

2-Year Warranty Coverage: Provides a 2-year warranty period for all assembled PCBA products.

Advanced Special Processes: Supports buried/blind holes, impedance control, and embedded components.

Company profile

Mu Star (shenzhen) Industry Co., Ltd.

Guangdong, China

CertifiedBusiness Type: Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 5 Years CertifiedNearest Port: Shenzhen PortAverage Response Time: ≤11.85h

AI-Powered supplier vetting

SummaryMu Star Group is described as a Shenzhen-based EMS and PCBA/OEM/ODM customization provider founded in 1998, serving medical, health, automotive, new energy, and industrial-control applications. It reports professional R&D capability, 3D design services, broad customization options, more than 10 production lines, 50 quality-control staff, eight R&D engineers, and stated lead times within 15 working days in both off-peak and peak periods. Its disclosed business scope also covers electronic components, integrated-circuit design services, intelligent robots, AI hardware, and IoT devices. However, no supplier-management-system certification is reported, service-capability assessment procedures and complaint handling are not clearly documented, SDK availability is absent, and sustainability compliance statuses are unknown. The available information does not identify specific customer cases.

Supplier typeThe supplier is described as a Shenzhen-based company providing one-stop PCBA, PCB manufacturing, component sourcing, SMT, enclosure assembly, programming tests, OEM, and ODM services. Its registered business scope also includes electronic components, integrated-circuit design services, AI hardware, robots, and IoT devices, while the company type is identified as a trading company.

After-Sales capabilityThe supplier reports an ability to handle customer complaints effectively as 'Others,' and its corrective/preventive-action mechanism is also recorded as 'Others.' More importantly, the service-capability assessment has no written procedures or followed records, so a structured and verifiable after-sales system is not demonstrated.

R&D capabilityThe supplier is identified as a professional technical supplier with R&D capability and offers 3D software design services. Its stated scope includes integrated-circuit design services, intelligent robots, AI hardware, intelligent devices, and IoT products; however, no SDK is available, which limits the disclosed development-support capability.

Production capacityThe supplier describes one-stop PCBA/OEM manufacturing capabilities, operates above 10 production lines, employs 50 quality-control staff, and reports lead times within 15 working days in both off-peak and peak seasons. These stated resources and delivery figures provide explicit evidence of substantial production capacity.

Customization capabilityThe supplier provides 3D software design services and explicitly offers customization from samples, customization from designs, full customization, minor customization, and flexible customization. Its PCBA, OEM, and ODM service description further supports a broad customization offering.