For life-critical medical device applications, we provide ISO 13485 certified PCB & PCBA solutions, built on RayPCB’s medical-grade manufacturing system and PCBSync’s full-process compliance support for medical products. With a Class 10,000 clean production environment, full-process traceable quality control system, and high-precision manufacturing capabilities, our solutions meet the most stringent compliance, safety, and reliability requirements of the global medical device industry.
Application Scenarios
Patient monitoring equipment, medical imaging systems (ultrasound, C-arm X-ray, MRI), in vitro diagnostic (IVD) equipment
Surgical instrument control systems, electric operating table control boards, wearable medical devices, respiratory therapy equipment
Oxygen concentrator control motherboards, laboratory analysis instruments, rehabilitation medical equipment, portable blood glucose meters
Endoscope control boards, ECG monitor motherboards, for home medical care, clinical treatment, in vitro diagnosis, and life science scenarios
Custom Capabilities
Class 10,000 clean production workshop supporting high-precision assembly of miniaturized and highly integrated circuit boards for medical devices, with process optimization for medical-grade biocompatibility, sterilization resistance (ethylene oxide, gamma sterilization), and long-term stable operation in clinical environments
Full production strictly following IPC-A-610 Class 3 medical-grade workmanship standards, with customizable solutions for rigid-flex PCB, HDI board, and ultra-thin flex PCB for portable medical devices, adapting to the miniaturization and portability trends of modern medical equipment
Quality Assurance
Exclusive quality control system for medical products, with full batch traceability from raw material procurement to finished product delivery, and complete material certification, production process documentation, and test reports to meet FDA, CE, and global medical device regulatory approval requirements
Multi-stage, full-dimensional strict inspection for every medical PCBA, including 100% AOI, full X-ray inspection of all BGA/QFN components, flying probe testing, and ICT in-circuit testing
Customizable functional test fixtures for clinical function verification, burn-in testing, and insulation withstand voltage testing to eliminate clinical use risks after delivery
Full production certified by the ISO 13485 medical industry quality system
Value-Added Services
Full-process exclusive services for medical customers, including R&D-stage DFM optimization, compliant medical-grade component procurement, rapid prototyping, trial production-stage process verification and compliance document output, as well as mass production full-process traceability and UDI identification adaptation
Dedicated medical project engineering team providing 1-on-1 full-process follow-up and 7×24 technical support, with rapid prototype delivery in as fast as 3 days to support R&D iteration cycles
