Ho Brian

At Mobio Interactive, I lead the quality and regulatory systems for a digital therapeutics and SaMD platform. I built its QMS, led ISO 13485/MDSAP Stage 1 with Intertek, and achieved a recommendation to proceed to Stage 2 with no major findings.

I own the DHF, CER and controlled technical documentation linking design controls, clinical evidence, software lifecycle, risk management, V&V and PMS/PMCF. I lead FDA 510(k) preparation, EU MDR documentation, Health Canada ITA submissions and Singapore clinical submissions.

Previously at DSV Solutions, I implemented ISO 13485 across multiple sites and achieved certification, secured GDP certification, and delivered zero-finding external audit outcomes across IMS and GDPMDS. I have also led quality, compliance and sustainability programs at Martin Brower, supported pharmaceutical quality and regulatory work at Vallaurix, and worked in GMP gene-therapy and biomedical research environments.

Across digital health, medical devices, pharmaceuticals and life sciences, I build practical quality systems covering CAPA, audits, supplier assurance, document control, change control, training, risk management and continual improvement.