The HealthTech Activator and Te Tītoki Mataora MedTech Research Translator are pleased to host our next workshop 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:

Regulatory basics including standards, guidelines, directives, laws, regulations and their interactions.
Principles of safety and performance of medical software.
Software development processes compliant with IEC 62304.
Special features of IEC 62304: The interaction between processes of development and change.
Software testing and validation.
Requirements for cybersecurity.

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

Event details

Hosted in-person at Callaghan Innovation, Auckland.

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

Attendance is limited to two attendees Tickets are limited to 2x individuals per company/research group to ensure greater opportunity for others to engage.

Hosted by:

Annett Arndt:

Anne started her career as a software developer over 20 years ago, eventually working as a consultant on software projects in the food industry. On leaving the field of software development Anne changed to quality and process management, and for the last 10 years has worked successfully on the approval of medical products in Europe.

Anne joined the Johner Institute four years ago and since then has successfully supported customers in the approval of medical devices with a focus on software as a medical device. Subsequently, Anne moved from Europe to New Zealand and together with a European manufacturer, she took advantage of the 12-hour time difference and worked with a team 24 hours a day to launch a Covid tracking app onto the market after two months of successful cooperation.

In 2021, Anne was appointed as Director of Johner Institute New Zealand, and now supports clients in New Zealand and Australia in preparing their products for global approval. Anne’s focus remains on active medical devices including software. Her passion for regulatory compliance drives her to also support suppliers to medical device manufacturers, for example helping software developers and testers to understand the development of products following a regulatory framework."

Medical Software Regulatory Requirements