Medical Device PCB Assembly

 

 

1.Product Description

 

Medical Device PCB Assembly (PCBA) refers to the design, manufacturing, and testing of printed circuit boards tailored for medical equipment. These assemblies are critical for ensuring precision, reliability, and compliance with strict medical industry regulations (e.g., ISO 13485, FDA 21 CFR Part 820). Our PCBA solutions are engineered to meet the rigorous demands of life-critical applications, from diagnostic tools to implantable devices.

 

2.Key Specifications

(1)Design & Materials

• Layers: 1–16 layers, flexible/rigid-flex options.
• Materials: FR-4, high-frequency Rogers laminates, biocompatible substrates.
• Component Sourcing: Medical-grade ICs, connectors, and sensors (e.g., TI, Analog Devices).
• Precision & Testing
• Tolerances: ±0.1mm for high-density interconnects (HDI).
• Testing: 100% electrical testing, AOI (Automated Optical Inspection), X-ray inspection, and functional validation.
• Environmental Testing: Thermal cycling, humidity resistance, vibration, and EMI/EMC compliance.

(2)Certifications

ISO 13485, FDA QSR, CE Mark, RoHS/REACH compliance.

Full traceability (Lot/batch tracking) for FDA audits.

(3)Production Capabilities

Prototyping to high-volume production (up to 1M+ units/year).

Cleanroom assembly (Class 8–100,000) for implantable devices.

 

3. Application Scenarios

(1)Diagnostic Equipment

Examples: Blood analyzers, MRI/CT imaging systems, glucose monitors.

PCBA Role: Signal processing, sensor integration, data transmission.

(2)Wearable & Remote Monitoring

Examples: ECG patches, smart insulin pumps, IoT-enabled health trackers.

PCBA Role: Low-power design, wireless connectivity (Bluetooth/Wi-Fi), miniaturization.

(3)Surgical & Therapeutic Devices

Examples: Robotic surgical systems, infusion pumps, laser therapy tools.

PCBA Role: Real-time control, motor drivers, safety interlocks.

(4)Implantable Devices

Examples: Pacemakers, neurostimulators, cochlear implants.

PCBA Role: Ultra-reliable microelectronics, hermetic sealing, long-term biocompatibility.

(5)Emergency & ICU Equipment

Examples: Ventilators, defibrillators, patient monitors.

PCBA Role: Redundant circuitry, fail-safe mechanisms, rapid response.

 

 

 

4. About our company

BQC has been dedicated in EMS industry and is insist on providing professional manufacturing, OEM,and ODM services for electronic products to our vast domestic and overseas customers for over 22 years.

√Served in the EMS industry for almost 22 years.
√22 SMT lines, 5 THT lines, and 4 final assembly lines in China.

√4SMT lines, 4 DIP and Hand Soldenng line in Malaysia.

√ISO9001,ISO14001,IS013485 and IAPF16949 certified.

√Professional OEMODM R&D team service for you.

√Qualified supplier of Walmart IKEA. and GE.

√SPI,AOI,X-ray ICT inspection & testing.
√Prototype order, trial order, mass production order(have no requirement about the quantity for each order).

√You can check each component's price, L/T, brand, and kinds of engineer fees in our quotation.

√Customer-focused product development and manufacture tailored to your needs.

√We can give you a 30-day credit payment at least.

5. Certificates

We have a strong production and sales team, equipped with advanced processed devices, and checking and testing technology equipment. We abide by national laws and regulations, laying emphasis on environment and environmental production. To honest and appreciate to our customers. We've been worked with many domestic and overseas customers, like Walmart, Ikea etc. And we have already passed ISO 13485, ISO9001 and ISO14001: 2015. Our products quality can meet IPC-A-610F, MIL-STD-105D LEVEL II, UL/CE/ SGS/CSA/ ETL standard. With strict quality inspection and good purchasing capability, we can guarantee quality products and exact lead time

 

6.F&Q

 

Q1: BQC just produce only prototypes or customer can order production quantities ? BQC: BQC is EMS factory, we not only do prototypes, but also do mass production for our customer. Q2: Can you give us a favorable discount? BQC: Yes, if your requirements is reasonable, we will give you a discount based on the order qty.

 

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