Presented in collaboration by The Johner Institute New Zealand, Te Tītoki Mataora, and HealthTech Activator
Join us for an intensive exploration of regulatory requirements for Software in Medical Device (SiMD) and Software as a Medical Device (SaMD) products. This comprehensive workshop is a collaboration between The Johner Institute New Zealand, HealthTech Activator, and Te Tītoki Mataora.
The Opportunity and Venue
Scheduled for Thursday, the 3rd of August, 2023, between 9:00 AM and 12:00 PM NZST, this interactive forum will convene at 5 Sheffield Crescent, Christchurch, Canterbury 8053, New Zealand.
Delving Deeper
This three-hour immersive session aims to sharpen your expertise in real-world applications of regulatory mandates, with a specific focus on IEC 62304. The workshop will cater to a compact, half-day format to optimize your learning experience and facilitate a focused approach towards proficient software development.
As an introductory primer, it is designed to clarify the concepts around development, quality assurance, and regulatory compliance of medical software. The session will be particularly insightful for Regulatory Affairs Managers, Quality Managers, Product Managers, and Researchers eager to gain a holistic perspective of regulatory prerequisites. We’d also like to invite Software Developers, Architects, and Testers to access a technically-oriented version of this workshop.
Workshop Content
The key aspects that will be covered in the workshop include:
- Regulatory Fundamentals: Discover the network of guidelines, laws, standards, directives, and regulations, and how they interact.
- Process Comprehension: Get a grip on the development activities defined by IEC 62304, and understand the agile approach.
- Documentation Expectations: Unveil the essential deliverables as per IEC 62304 requirements, for instance, software requirements, software architecture, and software design.
- SBOM, SOUP, OTS: Decode the acronyms and their role in Quality and regulatory compliance.
- Software Risk Management: Get a handle on risk management as per ISO 14971 and IEC 62304 and learn about defining safety classes.
- Cyber Security: Delve into the mandatory requirements.
Participation is encouraged, so bring along your questions, insights, and experiences to enrich this interactive workshop.
Please note that the event has a cap of two attendees per company or research group, keeping the interactive and personalized nature of the workshop in mind.
Meet the Host
This knowledge-sharing endeavor is steered by Annett Arndt. Annett, a seasoned professional with a 20-year long career in software development and quality management, brings her rich experience and unique insights to her role as the Director of Johner Institute New Zealand. Her passionate dedication to regulatory compliance and focus on medical devices, specifically those with embedded software, has been instrumental in assisting numerous clients in New Zealand and Australia towards achieving global product approvals.
Registration
Please register via Eventbrite
