The HealthTech Activator and Te Tītoki Mataora MedTech Research Translator: Medical Software Regulatory Requirements

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.

Register for this event HERE