Quality Management Systems

Quality Management Systems (QMS) are essential in the healthtech as they ensure that medical technologies from software to devices are safe, effective, and compliant with regulatory standards.  

QMS Learning Series

The HealthTech Activator in partnership with Elevate MedTech (formerly Johner Institute New Zealand) has launched a one - year modular knowledge series, designed to make quality management more accessible for local health tech innovators.
 
Over 12 months, this practical and flexible program builds your understanding of ISO 13485 quality management requirements.
 
The series features:  

  • Quarterly topics
  • Articles
  • Webinars
  • Optional quiz - Certificate upon successful completion of the quiz

Quality Management Learning Series

Quarterly Topics

General Awareness & Education

  • What Is ISO 13485?
  • Understanding ISO 13485
  • Understanding QMS Requirements
  • SO 13485 Compliance & Audits
  • Webinar - Introduction to ISO 13485
  • Quiz
  • Whitepaper
FIND OUT MORE

Implementation & Best Practices

  • Step-by-Step QMS Guide
  • Top 10 Common Pitfalls
  • Aligning QMS with ISO 13485
  • Webinar - QMS Setup Example
  • Quiz
  • Whitepaper
Coming soon Oct 2025

Risk & Efficiency Focus

  • Risk Management in QMS
  • Lean Compliance Approaches
  • Compliance as Competitive Advantage
  • Webinar - Risk & OMS
  • Quiz
  • Whitepaper
Coming soon Jan 2026

Audits & Inspections

  • Audits & Inspections Overview
  • Preparing for an Audit
  • Internal Audits Process
  • CAPA in QMS
  • Webinar QMS & Audit Steps
  • Quiz
  • Whitepaper
Coming soon April 2026

General Awareness & Education

Develop your understanding of ISO 13485 and why it matters. 

Register to attend

Recording available after the webinar

HealthTech Activator & Johner Institute NZ
October 2025

Introduction to ISO 13485 – Quality Management Series Webinar

We hosted the first Quality Management Series webinar - Introduction to ISO 13485 on the 7 October. In this webinar Anne Arndt, unpacks the requirements of ISO 13485 and how to engage leaders and support teams to embed quality practices.

Quiz

Ready to test your knowledge? Take a few minutes to complete the quiz. Earn a certificate of completion when you achieve a score of 13 or more.

Take Quiz

Whitepaper

This whitepaper explores the practical steps medical device organisations can take to develop and sustain a quality-driven culture, with ISO 13485 as the structural backbone.

Link to Whitepaper

Implementation & Best Practices

Understand how to set up a QMS in line with ISO 13485.

Risk & Efficiency Focus

Learn how to integrate compliance into everyday processes.  

Coming Soon Jan 2026

Audits & Inspections

Understand how to prepare for inspections and avoid recurring issues.    

Coming Soon April 2026