QMS Webinar: Driving Quality Forward - Risk & Efficiency Strategies for ISO 13485 Success

Are you ready to learn how to turn ISO 13485 from a regulatory obligation into a strategic advantage? 

Join us for the third webinar in the Quality Management Series: Driving Quality Forward – Risk & Efficiency Strategies for ISO 13485 Success, taking place on Tuesday 24 March 2026. 

In this session Anne Arndt, will share practical insights on:  

• How risk management can drive a proactive QMS 

• How lean implementation cuts complexity and cost 

• How strong compliance can accelerate market access and strengthen your competitive position 

Guest Speaker: Anne Arndt will be joined by guest speaker Alexander Thern, Consultant. Alexander regularly reviews QMS implementations as an auditor for DQS, a European Notified Body.  With an advanced degree in Physics and extensive experience as a lead auditor for ISO 13485, ISO 9001, MDD 93/42 and MDSAP, he has seen more quality systems up close than most teams will encounter in a lifetime. 

That perspective has shown him which risk-based approaches genuinely make a QMS robust, and which “compliant on paper” solutions quietly create gaps, delays, and regulatory headaches. In this webinar, he will share what really matters when designing and implementing a lean, risk-driven QMS, so you can focus your effort where auditors, regulators and markets actually care, and build a system that protects patients, supports your teams, and speeds market access. 

Here’s What We’ll Explore 

• How to build a proactive, risk-based QMS under ISO 13485 rather than reacting to problems 

• Lean approaches to simplify ISO 13485 implementation and keep your QMS efficient and user friendly 

• How to embed risk management into everyday activities across the product lifecycle 

• Ways to avoid "paper compliance" and make processes genuinely effective for your teams 

• How ISO 13485 compliance can support faster market access and create a clear competitive edge 

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 and apply ISO 13485 effectively.    

Event details: 

• Tuesday 24 March 2026, 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 20 March 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.