Hosted by the HealthTech Activator, the Medical Software Regulatory Requirements workshop will take place in Christchurch, on 6 November, 9am-3pm.
This workshop will focus on the regulation requirements for medical software products, including software in, or as, a medical device.
This compact workshop aims to increase your competence in the practical implementation of regulatory requirements (in particular IEC 62304) while promoting efficient software development.
It is an introduction to the topic of development, quality assurance, and approval of medical software (software as a medical device or medical device software) aimed towards researchers and early-stage start-up companies.
This workshop will help you understand:
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Regulatory basics including standards, guidelines, directives, laws, regulations and their interactions
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Principles of safety and performance of medical software
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Software development processes compliant with IEC 62304 including verification and validation
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Special features of IEC 62304: The interaction between processes of development and change
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Requirements for cybersecurity
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Market approval / clearance and ongoing changes.
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This will be an interactive session with opportunities for discussions and questions, so come ready to participate!
Who is this workshop for?
The workshop is aimed at researchers and early-stage companies who are developing medical devices that contain software (SiMD) or software as a medical device (SaMD). The content is aimed at an introductory level to support a better understanding of the regulatory aspects of SaMD and SiMD products.
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If you are a researcher or a clinician, please select the Researcher ticket
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If you are a start-up company, please select the HealthTech Activator ticket.
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Event details:
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Workshop: Medical Software Regulatory Requirements (Morning tea & lunch included)
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Hosted in-person at University of Canterbury, HP seminar room in the John Britten building, Christchurch
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Cost: $50 (incl. GST and booking fee)
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Attendance is limited to two attendees per company/research group.
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To confirm your place please register no later than 30 October 2025. Spaces are limited, and a waitlist will open once the workshop is fully subscribed.
About the presenter:
Anne Arndt, Director of Johner Institute New Zealand
Anne is the 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.
Contact the HealthTech Activator (HTA) team for more information or explore the HTA website here.