Quality Management Systems Webinar: A step-by-step example for setting up a QMS

Join us for the second webinar in the Quality Management Series – A step-by-step example for setting up a QMS - taking place on Wednesday 3 December 2025.  

Are you ready to build a robust Quality Management System (QMS) that supports compliance, efficiency, and growth? 

 Join us for an in-depth webinar designed to guide you through the essential steps of QMS implementation and share best practices that set successful teams apart. 

In this session, we’ll cover: 

• How to identify applicable regulatory requirements 

• Defining the scope of your QMS 

• The importance of management commitment and the role of the Management Representative 

• Choosing the right tools to support your QMS 

• Building your team: understanding the difference between employee roles and regulatory roles 

• Identifying and mapping key processes 

• What information belongs in a process – and what doesn’t 

• How to write clear, effective Standard Operating Procedures (SOPs) 

• Why teamwork is critical – and how working in silos can lead to failure 

• What comes after setup – maintaining and improving your QMS 

Whether you're just starting your QMS journey or looking to refine your existing system, this webinar will provide practical insights and actionable strategies to help you succeed. 

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: 

• Wednesday 3 December 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 1 December 2025 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.