Medical and automotive electronics face some of the most demanding quality requirements in the industry—zero-defect expectations, stringent regulatory compliance, and rigorous reliability standards that must be documented and auditable. Studio Electronics delivers turnkey PCB manufacturing for medical and automotive electronics, backed by ISO13485 and IATF16949 certifications and a manufacturing infrastructure built for regulated products. As a specialized provider of PCB assembly in China, we understand the unique requirements of these industries—from biocompatibility and patient safety to vibration resistance and thermal cycling. Our certified quality systems, advanced inspection equipment, and comprehensive testing capabilities ensure your boards meet the highest industry standards.

• 12 Fully Automated SMT Lines – High-speed placement with ±25μm accuracy; supports 01005 to BGA; consistent, repeatable results
• Automatic Wave Soldering – Programmable closed-loop control; ±1°C accuracy; consistent THT soldering
• Programmable Automated Soldering Robots – ±0.05mm positional accuracy; precision selective soldering
• 3D SPI – Paste inspection per board; real-time feedback; data stored for traceability
• 3D AOI – AI-assisted defect detection; inspection data per board serial number
• 3D X-Ray – Automated void calculation for BGA and QFN; detailed reporting per board
• ICT – In-circuit testing per board; electrical validation; data stored for traceability
• FCT – Functional testing per board; custom fixtures for your product; simulated operation
• Flying Probe – Fixture-less testing for low volume PCB assembly and prototypes
• Reliability Laboratory – Thermal shock (-40°C to +125°C); temperature cycling; damp heat (85°C/85% RH); vibration; extended burn-in

• 100% Traceability – Every board has a unique serial number linked to component lot numbers, inspection data, and test results. Complete quality records available for regulatory audits.
• Documented Quality – All processes are documented and controlled per certification requirements. Non-conformance processes are defined and followed with root cause analysis.
• Risk Management – FMEA (Failure Mode and Effects Analysis) identifies potential failure points. Preventive actions are implemented to mitigate risks.
• Product Safety – For automotive applications, product safety requirements are integrated into quality planning. For medical devices, patient safety is the primary focus.
• Reliability Testing – Environmental stress testing validates board performance under real-world conditions. Thermal shock, vibration, damp heat, and burn-in testing are available.
• Design Control – For medical devices, design control processes ensure that product design, verification, validation, and changes are documented and controlled.

Choose Studio for turnkey PCB manufacturing for medical and automotive electronics—where certified quality systems, rigorous inspection, and comprehensive testing ensure your regulated products meet the highest industry standards.