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) and is aimed towards Software Developers, Software Architects and Software Testers. NOTE: Please follow this link if you are a Regulatory Affairs Manager, Quality Manager and Product Manager or Researcher seeking an overview of the regulatory requirements.

This workshop will help you with:

• Regulatory basics: Know the relevant guidelines, directives, laws, standards, regulations and their interaction
• Process: Know the development activities of the IEC 62304 and what deliverables to expect in each stage from your team
• Documentation: How to support the team so they can create lean and accurate documents that meet the requirements of IEC 62304 (e.g. software requirements, software architecture and software design)
• SOUP: Why the team uses Software of Unknown Provenance (SOUP) and what this means for the software development process and whether and how this affects risk management and post-market surveillance
• Software risk management (SRM): Understand how the SRM plays into risk management according to ISO 14971 and the definition of safety classes required by IEC 62304
• Cyber Security: Understand where the requirements come from and what kind of actions and documentation is expected

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.