Founded in Shenzhen in 2011, EMS-MEDICAL has grown into a trusted manufacturing partner for medical device companies across North America, Europe, and Asia-Pacific.
Each milestone represents an expansion of capability, a deepening of our regulatory expertise, and a strengthening of the trust our customers place in us.
Established as a specialized PCBA manufacturer with a focus on industrial electronics. 2 SMT lines, 50 employees, initial ISO 9001 certification.
First medical device customer engagement. Achieved ISO 13485 certification. Built initial clean room manufacturing capability. Began IPC-A-610 Class 3 training program.
FDA establishment registration as contract manufacturer. First CE-marked device shipped. Expanded to 4 SMT lines. Launched dedicated medical device NPI team.
Rapidly scaled ventilator and patient monitor electronics production. ISO Class 7 (Class 10,000) clean room commissioned. 6 SMT lines. Launched risk management framework per ISO 14971.
8 SMT lines operational. EU MDR 2017/745 transition readiness achieved. IEC 62304 software lifecycle processes integrated. Full IQ/OQ/PQ protocol framework deployed across all lines.
Advanced packaging (SiP, rigid-flex), miniaturized wearable sensor assembly, and AI-driven AOI. Expanded regulatory coverage for CFDA/NMPA markets. 400+ team members.
Our 8,000 square-meter facility in Shenzhen is purpose-built for medical electronics manufacturing, with dedicated clean rooms, ESD-protected floors, and environmental monitoring throughout.
8 high-speed lines with automated solder paste inspection (SPI), pick-and-place (0201 to 55mm BGAs), 12-zone reflow, and 3D AOI at every line.
ISO Class 7 (Class 10,000) clean rooms with continuous particle monitoring, HEPA filtration (99.97% at 0.3 micron), positive pressure cascade, and 22 +/- 2 degrees C / 45 +/- 5% RH control.
Multi-stage quality gates: SPI, pre-reflow AOI, post-reflow 3D AOI, X-ray (BGA/QFN), ICT, flying probe, boundary scan, functional test, and burn-in per device specification.
In a market with many EMS providers, our focused expertise in medical electronics creates measurable differences for our customers.
Unlike generalist EMS providers, we do not split attention across automotive, consumer, or industrial verticals. Our QMS, team training, and facility are purpose-built for medical.
We do not just manufacture to print — we partner with your regulatory team. Our documentation package is designed to slot directly into your 510(k), PMA, or Technical File submission.
Medical devices have 10-20 year lifecycles. We maintain component obsolescence monitoring, last-time-buy management, and bridge inventory strategies to keep your devices in production.
We support medical device registration in all major global markets. Our documentation and manufacturing practices meet the requirements of each regulatory framework.
Your device deserves a manufacturing partner who understands the regulatory landscape as deeply as the assembly process. Let us demonstrate the difference.
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