Scaling Medical Device PCB Assembly with Custom-Developed Automated Test Fixtures

Supply Chain Agility & Scalable Production of Plasma-Coated PCB Assembly

A leading U.S.-based innovator in orthopedic recovery solutions partnered with Syrma Johari MedTech Ltd. (SJML) to scale manufacturing of its Class II, FDA 510(k)-cleared cold and compression therapy system. The engagement focused on large-scale PCB assembly, supply chain management, and end-to-end testing.

SJML leveraged its global supply chain network to multi-source critical components, ensuring quality and cost optimization. The team seamlessly scaled PCB assembly (PCBA) for high-performance medical devices, aligned with ISO 13485, FDA 21 CFR Part 820, and IPC Class 3 requirements.

To enhance reliability, PCBAs were plasma-coated and validated for environmental protection. A key differentiator of the project was the in-house design and development of automated test fixtures, enabling high-speed and accurate functional testing.

Key Outcomes

• ~50,000 PCBAs manufactured annually with full traceability and documentation
• 3x faster test cycle (30 sec to 3 min per unit)

Looking to scale complex PCBA manufacturing with precision and compliance?

Syrma Johari MedTech brings decades of expertise in medical-grade electronics manufacturing, testing, and regulatory-compliant production. With a robust ecosystem comprising 14 global facilities and 34 high-speed SMT lines, we deliver turnkey PCBA solutions for medical devices, ensuring rapid scalability for global markets.