
Regulatory Failure & Microscopic Solder Voiding in Medical Electronics
Healthcare, surgical, and diagnostic devices require absolute consistency in solder joint integrity, sterility, and lot-level traceability. Hidden voids in fine-pitch BGAs, ionic contamination, or unverified broker materials trigger strict regulatory rejections (FDA/MDR) and catastrophic field recalls.
Every build is validated under certified ISO 13485 cleanroom workflows and IPC-A-610 Class 3 acceptance criteria. We perform 100% 3D SPI, dual-angle 3D AOI, and micro-focus 3D X-Ray inspection maintaining micro-BGA void rates strictly < 10%, backed by full lot date-code MES traceability from bare fab to turnkey PCBA.











