Workshop - Medical Software Regulatory Requirements

The HealthTech Activator and Te Tītoki Mataora are pleased to host our next workshop on the regulation requirements for medical software products, including software in or as a medical device. This half-day, 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 Regulatory Affairs Managers, Quality Managers, Product Managers and Researchers aiming to understand the overview of regulatory requirements. NOTE: Please follow this link if you are a Software Developer, Software Architect or Software Tester for the more technical version of this workshop - please only register for one version as they contain very similar content.

This workshop will help you with:

• Regulatory basics: How to find the relevant guidelines, directives, laws, standards, regulations and their interaction
• Process: Know the development activities of IEC 62304 and can the team go agile
• Documentation: What are the expected deliverables following the requirements of IEC 62304 (e.g. software requirements, software architecture and software design)
• SBOM, SOUP, OTS: What does it mean and how does it play into Quality and regulatory
• Software risk management: Understand the interaction of risk management according to ISO 14971 and IEC 62304 and the definition of safety classes
• Cyber Security: Understand the requirements

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

Tickets are limited to 2x individuals per company/research group.

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."