I founded TrustedTraceMed after spending over a decade inside the healthcare domain — working on X-ray systems, clinical trial platforms, and AI-based diagnostic tools, including a system for dental pathology prediction using X-ray annotation and AI/ML algorithms.
In my most recent role before founding the company, I built a complete ISO 13485-compliant QMS from scratch for a Class IIa SaMD product in Singapore. I personally wrote the SOPs, implemented risk management (ISO 14971) and usability processes (IEC 62366), managed clinical evaluations, supported UKCA compliance, and acted as the primary contact with notified bodies and audit companies — leading the system through certification and external audits.
I bring a strong product mindset and business analysis background. I've worked hands-on with product owners, designed workflows, written user stories, modelled business processes, and translated clinical requirements into technical specifications. My experience spans every phase of the product lifecycle: from discovery and pre-sales through launch and post-market support.
Most recently, I developed a compliance strategy for an AI-based image analysis system, gaining deep familiarity with the regulatory challenges around explainability, data annotation, and algorithm validation — particularly under MDR and UKCA frameworks.
Today I work as an outstaff consultant, fully embedded within client teams. I guide developers, collaborate with suppliers, manage compliance gaps, support during regulatory calls, train team members, and prepare teams for audit. This integrated approach is what makes TrustedTraceMed different.
