QMS Webinar - Risk-Driven Internal Audits: Turning ISO 13485 Checks into Real Insight

Are you ready to learn how to turn your next audit cycle into a driver for improvement? 

Join us for the fourth and final webinar in the Quality Management Series:  Risk-Driven Internal Audits: Turning ISO 13485 Checks into Real Insight, taking place on Tuesday 16 June 2026.  

Internal audits are often treated as a checkbox exercise, but ISO 13485 expects much more than a schedule and a stack of checklists.  

In this one‑hour webinar, you’ll learn how to move beyond tick‑box internal audits and create an audit programme that adds real value.  

 In this session, you’ll learn: 

• Why ISO 13485 expects more than checklist‑based internal audits and what that means in practice 

• How to design risk‑driven internal audits that focus on patient safety and business‑critical risks 

• How to link your audit programme with risk management, complaints, CAPA, and change management 

• How to prioritise audit focus based on real risk, rather than evenly sampling clauses 

• Turning audit findings into actionable insight that supports improvement and performance 

Whether you're just starting your QMS journey or refining an existing system, this webinar will provide actionable takeaways you can apply immediately.   

Who should attend?  

HealthTech companies developing medical devices or health software for global markets. This session will help you understand how to design and run risk-driven internal audits that focus on patient safety and business performance.     

Event details:  

• Tuesday 16 June 2026, 11am – 12pm including Q&A  

• Cost: Free  

• Location: Online (Zoom) Questions can be submitted via the Zoom chat during the session.   

• Attendance is limited to two attendees per NZ-based HealthTech company to support an interactive session.   

The webinar will be recorded and shared on the HTA website (Q&A not included). 

Register by 12 June 2026 to secure your spot.   

Want to catch up on the series? Explore all the QMS learning series resources here.   

This series is brought to you by the HealthTech Activator in partnership with Elevate MedTech and is designed to support NZ-based HealthTech companies navigating ISO 13485 compliance.   

About the presenter: 

Anne Arndt, Director of Elevate MedTech

Anne brings over two decades of experience in regulatory affairs. Originally trained as a software developer, she worked across Europe in quality and process management before specialising in the certification of medical devices. Since 2021, she has been supporting New Zealand and Australian companies in preparing their products for global approval. Her work often focuses on early-stage teams, including suppliers and developers who need to align innovation with regulatory expectations.