Kia ora
The HealthTech Activator in partnership with Johner Institute New Zealand is launching a new one-year modular knowledge series, designed to make quality management more accessible for local health tech innovators.
The series focuses on the practical basics of building and managing a Quality Management System (QMS) – a key step for companies developing medical devices and software for global markets.
Over 12 months, this practical and flexible program will build your understanding of ISO 13485 quality management requirements. It features blog articles, online webinars, white papers and optional assessments. Each quarter covers a different area: from introductory guidance and implementation strategies, through to risk management and audit preparation. There are optional assessments after each block to help track your understanding, and a certificate issued at the end of the full series.
Content at a glance:
- Q1 July – Sept 2025: General awareness – what ISO 13485 is, and why it matters
- Q2 Oct – Dec 2025: Implementation – how to set up a QMS in line with the standard
- Q3 Jan – Mar 2026: Risk & efficiency – integrating compliance into everyday processes
- Q4 Apr – Jun 2026: Audits – preparing for inspections and avoiding recurring issues
Each quarter we will feature:
- 3–4 expert-written articles
- A live, interactive webinar led by Anne Arndt, Quality & Regulatory Affairs specialist
- Optional assessments with Certificates of Completion per topic
- A comprehensive whitepaper
- Curated external resources for deeper learning
Complete all four quarterly assessments and earn a Certificate of Completion for the full program - a verified recognition of your ISO 13485 knowledge development.
Why Join?
- Structured, progressive learning over 12 months
- Real-world examples for practical application
- Flexible and self-paced content delivery
- Live Q&A opportunities with expert Anne Arndt
- Certifications to demonstrate verified competence
The series is led by Anne Arndt, 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.
Don’t miss this opportunity to strengthen your quality systems and ISO 13485 capabilities.
QMS learning series updates:
As an HTA subscriber, you’ll automatically receive updates for our new QMS learning series. If this isn’t relevant for you, you can update your preferences anytime — just click here and untick Updates on HealthTech Activator (HTA) - Quality Management System (QMS) learning series.
For questions, contact us hta@callaghaninnovation.govt.nz.
Mā te wā,
HealthTech Activator team
Callaghan Innovation
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