Insights and key takeaways from the Medical Software Regulatory Requirements Workshop on the 27 May, facilitated by Anne Arndt, Director of the Johner Institute New Zealand.
On Tuesday, 27 May, the HealthTech Activator (HTA), in collaboration with Ti Toki Mataora (TTM), delivered a full-day workshop dedicated to the regulatory requirements that shape the development of medical software. Led by Anne Arndt, Director of the Johner Institute New Zealand, the workshop brought together innovators, developers, and leaders from across Aotearoa’s health tech sector.
Anne brought not just technical expertise, but an intuitive ability to make regulation approachable. She opened the session by asking the room, “Who here enjoys cooking?” and returned to the analogy throughout the day. Just like in cooking or baking, the ingredients, standards, regulations, and processes are all available, but it’s how you apply them that matters.
With over a decade of regulatory experience and a dual background in computer science and business, Anne effectively bridged technical, clinical, and commercial perspectives while fostering open, collaborative discussion.
Throughout the day, Anne guided participants through the practical application of key international standards like IEC 62304 (software lifecycle), IEC 82304-1 (health software), IEC 81001-5-1 (cybersecurity), and ISO 14971 (risk management). These were contextualised alongside regional and global regulatory expectations, including FDA and EU MDR frameworks.
Rather than treat these frameworks as abstract rules, Anne focused on how they directly relate to product planning, development workflows, and documentation practices. Topics like risk classification, cybersecurity, usability, SOUP (Software Of Unknown Provenance), and lifecycle documentation were explored through discussion and tailored examples.
A key strength of the workshop was its adaptability. Whether participants were just starting their regulatory journey or preparing for market certification, the session offered relevant insights. Anne responded to specific questions about product types, team structures, and development stages, making the material practical, no matter the context.
The approach allowed startups and established teams alike to assess where they stood, what gaps to close, and how to move forward more strategically.
Participants left with a clearer understanding of:
Attendees shared positive reflections on the session’s value, delivery, and key takeaways:
“It was a great session. I definitely learnt something new, especially related to compliance and regulations possibly required for my AI product.”
“Really great event that was very well presented.”
When asked what the most valuable part of the workshop was and why, one participant shared:
“Knowledge of the Presenter, HTA Callaghan Innovation representatives, support and being able to connect with others who are also on similar pathways.”
This workshop was a focused and practical step toward strengthening regulatory capability across Aotearoa’s healthtech sector. Designed to demystify key international standards and frameworks, it offered participants a chance to engage directly with the concepts, ask questions, and understand how to apply them in their own product contexts.
As part of a broader effort by HTA and TTM to build capability and support HealthTech innovators, the session aimed to equip local innovators with the tools to meet global expectations — reducing risk, improving product quality, and accelerating progress toward compliance.
For many attendees, the workshop provided not only clarity but also a renewed sense of direction. If you missed this one, there are more sessions and resources on the horizon. In the meantime, HTA and TTM are here to support your next steps with tailored guidance and tools.
Are you a HealthTech Innovator interested in developing and refining your commercial strategy? We encourage you to join us for a future workshop. Check out the HTA events page for upcoming events Events | HealthTech Activator
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