Join us for an insightful workshop centered on the regulatory landscape of Software in Medical Device (SiMD) and Software as a Medical Device (SaMD) products. This event is jointly presented by Te Tītoki Mataora and HealthTech Activator, key players in the health tech industry.
Details and Location
The workshop is scheduled for the 3rd of August, 2023, from 1:00 PM to 5:00 PM NZST. The venue is 5 Sheffield Crescent, Christchurch, Canterbury 8053, New Zealand.
A Peek Inside the Event
Over four intensive hours, we aim to enhance your practical skills in implementing regulatory requirements, specifically IEC 62304, and to foster efficient software development practices. This interactive event serves as a gateway into the realms of medical software development, quality assurance, and regulatory approval.
Geared towards Software Developers, Architects, and Testers, this workshop delves into:
- Regulatory Essentials: Understanding the network of guidelines, directives, laws, standards, and regulations, and their interplay.
- Process Know-how: Grasping the development activities under IEC 62304 and anticipating the expected deliverables at each phase.
- Documentation: Learning to generate streamlined and accurate documents in compliance with IEC 62304.
- SOUP: Decoding the impact of Software of Unknown Provenance (SOUP) on the software development process, risk management, and post-market surveillance.
- Software Risk Management (SRM): Realising the role of SRM in risk management as per ISO 14971 and IEC 62304.
- Cybersecurity: Unveiling the origin of requirements and the expected actions and documentation.
Remember, interactive participation is key! Please note that each company or research group is limited to two participants.
The Host: Tyler Harmon
Tyler Harmon, a seasoned medical device consultant with specialized skills in Software as a Medical Device and cybersecurity, brings an impressive wealth of experience to our team. Tyler’s proficiency in addressing cybersecurity risks across products and enterprise systems has benefitted a diverse clientele, from start-ups to global corporations, including Apple and Fisher & Paykel Healthcare. His combined understanding of technical architecture, compliance, and quality management is sure to enrich the learning experience at the workshop.
Please register via Eventbrite