SJML provide medical PCBA manufacturing services engineered for the reliability, traceability, and quality demands of regulated medical devices. Our capabilities include high-mix SMT assembly, through-hole assembly, automated inspection, functional testing, conformal coating, and box-build integration for complex MedTech systems.
From prototype builds to full-scale production, SJML supports OEMs with scalable manufacturing, advanced testing infrastructure, controlled production environments, and integrated supply chain management to accelerate commercialization while maintaining stringent quality and performance standards.
Every PCBA is built with controlled processes, in-line verification, and traceability to ensure consistent performance and regulatory compliance.
Lean Manufacturing and Six Sigma Methodologies
Continuous Improvement and Yield Optimization
Operator Training and Standardized Work Instructions
Partner with a design-led MedTech CDMO that integrates PCB assembly, process engineering, and regulatory-aligned manufacturing—ensuring precision, reliability, and scalable delivery.
We provide PCB assembly services for a wide range of medical devices across multiple risk classes. Our experience includes diagnostic equipment, patient monitoring systems, therapeutic and rehabilitation devices, medical aesthetic platforms, and surgical systems.
Yes. Our medical PCB assembly solutions are customized as per your volume needs. We help you scale efficiently from prototypes and pilot builds to mass production. Our teams participate early through DFM reviews, tooling development, and process validation to streamline production scale-up.
We apply strict process control and inspection rigor across all volumes using in-line 3D AOI, in-circuit testing, functional testing, and X-ray inspection where required. Each production stage includes traceability and monitored checkpoints, allowing issues to be identified and addressed before they affect downstream processes.
Yes. Our engineering teams engage early in the design phase to conduct DFM and DFA reviews. This approach helps reduce production risk and supports smoother transitions from development to manufacturing.
We manage changing volumes and product variants through flexible production planning, buffer strategies, and close coordination with customer teams. Agile work cells, digitally guided work instructions, and disciplined lean manufacturing practices support quick transitions between variants while maintaining throughput across high-mix, low-volume builds.
Our PCB assembly processes follow global regulatory and environmental requirements applicable to medical device manufacturing. We operate within an ISO 13485–certified framework and conform to IPC-A-610 Class 3 standards, along with FDA 21 CFR Part 820 and relevant IEC requirements.
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