About
IXCIO exists so that an international manufacturer can enter South Africa with one local partner who understands both the regulation and the market — and who takes on the regulatory responsibility rather than just advising on it.
Founder & Regulatory Affairs Lead
Annemarie is a South African regulatory affairs specialist focused on AI-enabled medical devices and software as a medical device. Her research examines post-market surveillance and regulatory reliance for AI-enabled devices across African jurisdictions, with South Africa's SAHPRA framework as the primary case.
She holds an MPhil in the Philosophy and Ethics of Psychiatry and comes from a background in psychology, which shapes a particular interest in how software and AI devices are evaluated, monitored and governed once they're in clinical use.
Through IXCIO she works directly with manufacturers on classification, registration pathway, reliance strategy and local representation, and manages a network of South African specialists for the work that sits outside her own remit.
IXCIO is the company behind Aletia Index, an independent regulatory-intelligence initiative that tracks how AI/ML medical devices are regulated across major jurisdictions. The same discipline — primary sources, dated, with scope stated — is applied to IXCIO's client work.
We tell you what we don't know. Where a requirement depends on product-specific facts, or where South African practice is still settling, we say so rather than paper over it.
We hold the responsibility, not just the opinion. As licence holder and authorised representative, IXCIO is accountable to SAHPRA for your registration. That changes how carefully the work is done.
One point of contact. Whatever a task requires — a local specialist, an importer, a translator, a clinical contact — you deal with IXCIO and IXCIO deals with them.
Primary sources, dated. Regulatory positions we rely on are traced to the SAHPRA or statutory document they come from, with the date they were last checked.