May 27, 9 AM – 3 PM NZST | Location: Callaghan Innovation, Auckland | Cost: $50
Johner Institute New Zealand, in collaboration with HealthTech Activator, is hosting an interactive workshop on the regulatory requirements for medical software, including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).
This workshop is designed for researchers and early-stage start-ups looking to understand the essential regulatory frameworks, particularly IEC 62304, and how to efficiently develop compliant medical software.
Workshop details
Date: Tuesday, May 27, 9 AM – 3 PM NZST
Location: Callaghan Innovation, Auckland
Cost: $50 (incl. GST and booking fee)
Capacity: Limited to 2 attendees per organisation
Key topics covered
- Regulatory basics, including standards, guidelines, and laws
- Software safety, performance, testing, and validation
- Cybersecurity and compliance requirements
- The connection between software development and regulatory processes
The session will be led by Annett Arndt, Director of Johner Institute New Zealand, who has extensive experience in software development, quality assurance, and medical device compliance. With her background in both software engineering and regulatory approval, this workshop will provide practical insights into the challenges and solutions in this space.
