Bringing medical software to market can be complex, particularly when regulatory expectations are unclear. This workshop is designed to help you confidently navigate the requirements for software in, and as, a medical device (SiMD and SaMD), before costly mistakes are made. 

Hosted by the HealthTech Activator and Te Tītoki Mataora, this workshop will be held in Auckland, on 14 May, 9am-3pm, with a pre-workshop webinar on 12 May, 11am – 12pm.  

The pre-workshop webinar and whitepaper are ideal for those working in the SaMD space who may not have a strong software background. Attending will help you get the most out of the in-person workshop. 

About the Workshop 

This workshop provides a practical introduction to the regulatory requirements for medical software products, including software in, or as, a medical device.     

Designed for researchers and early‑stage startups, this compact session will help you build competence in implementing key regulatory frameworks (with a focus on IEC 62304) while supporting efficient, safe software development. 

This workshop will help you understand:   

• How regulatory frameworks fit together, and what applies to your software product 

• How to design and develop medical software that meets safety and performance expectations 

• How to apply IEC 62304 in a practical, startup-friendly way 

• How to approach verification, validation, and managing software changes 

• How to address cybersecurity requirements in medical software 

• What’s required for market approval or clearance, and how to manage ongoing updates 

This will be an interactive workshop with opportunities for discussions and questions, so come ready to participate!  

Pre-Workshop Materials 

To help set the scene, participants will receive:  

• A pre-workshop webinar on the 12 May, 11am-12pm (a recording will be available for those unable to attend live) 

• A white paper, providing a high-level overview of key terminology, concepts, and acronyms.  

Who is this workshop for?  

Designed for researchers and early-stage companies developing SiMD and SaMD products, this introductory workshop builds a practical understanding of the regulatory requirements that apply.    

This workshop is hosted in partnership by Te Tītoki Mataora | MedTech Research Translation and the HealthTech Activator.  

Event details:  

• Workshop: Medical Software Regulatory Requirements (Morning tea & lunch included)   

• Hosted in-person at, University of Auckland Business School: Sir Owen G Glenn Building 12 Grafton Road, Level 3 - Room 260-317, Auckland CBD.  

• Cost: $50 (incl. GST and booking fee)  

• Attendance is limited to two attendees per company/research group.  

To confirm your place please register no later than Thursday 7 May 2026. Spaces are limited, and a waitlist will open once the workshop is fully subscribed.