Introduction to ISO 13485 – Quality Management Series Webinar

We are excited to announce the first webinar in the Quality Management Series – Introduction to ISO 13485 – taking place on 7 October 2025. 

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

If you followed our first article series, you now have an overview of ISO 13485 and understand why, as a medical device manufacturer, you must comply with this standard. But as highlighted in the articles, compliance should not be a tick-box exercise.  

In this webinar Anne Arndt will break down how to: 

• Get busy leaders genuinely engaged in ISO 13485. 

• Inspire your team to take ownership of compliance. 

• Make the requirements clear, relatable, and easy to follow. 

 We are looking forward to sharing expert insights, real-world examples and practical tips! 

Who should attend? 

HealthTech companies developing medical devices or health software for global markets. This webinar will help with understanding and applying ISO 13485.    

Event details: 

• 7 October 2025, 11 am – 12 pm including Q&A 

• Cost: Free 

• Location: Online (Zoom) 

• Attendance is limited to support an interactive Q&A session.  

• Questions can be submitted via the Zoom chat during the session.  

• The webinar will be recorded and available on the HTA website webinars page post-event, the Q&A portion will not be included in the recording.  

Attendance is limited to two attendees per NZ-based HealthTech company.  

Register by 2 October 2025 to secure your spot.  

Want to catch up on the series? Visit the HTA articles page and filter by “QMS series” 

About the presenter: 

Anne Arndt, Director of Johner Institute New Zealand 

Anne is the Director of Johner Institute New Zealand, an international consultancy specialising in medical device regulation. 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.