We are pleased to invite you to the upcoming SAMED Regulatory Forum, where we will focus on AI and Medtech – Navigating Change, Trends, and Readiness in Regulation.

Artificial intelligence is rapidly reshaping how regulatory, quality, and compliance teams in the medtech sector operate. This session, facilitated by Vicore Health, a tech-enabled pharmaceutical and regulatory consultancy actively leveraging AI within its own workflows, will explore how these advances are influencing both organizational structures and individual roles in regulatory affairs.

Key Themes

• Industry and Regulatory Trends: How global frameworks (EU AI Act, FDA pilots) and SAHPRA’s digital transformation are redefining medtech regulation.
• Organizational Impact: How AI can streamline submissions, strengthen vigilance and audit readiness, and drive smarter decision-making while managing governance and data integrity.
• Personal Impact: Adapting to new ways of working, overcoming “AI anxiety” and building practical confidence to lead responsibly through technological change.

Who Should Attend

Whether you are a regulatory professional, quality manager or compliance officer, this session will help you understand where AI adds measurable value, what risks to manage and how to start building AI-ready teams and systems for the next era of medtech regulation.

Cost to Attend

• SAMED Ordinary & Associate Members: Free of Charge.
• Non-SAMED Members: Please contact alwi@samed.org.za for the cost to attend the event.

Registration

• Click here to register for the event