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 in a less technical version - please only register for one version as they contain very similar content.

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.

Hosted by:

Tyler Harmon

Tyler Harmon is a medical device consultant with expertise in Software as a Medical Device and Cybersecurity risks to both products and enterprise systems. His clients have included global corporations as well as startup companies. He was especially instrumental in the development and regulatory clearance of Apple's first Machine Learning medical device. Also with Apple, Tyler assisted in extending their ISO 27001 certification to cover the medical device division and leveraging Apple's existing systems to mitigate cybersecurity risks across their portfolio. Additionally, he worked with Draeger Medical throughout the pandemic to address urgent cybersecurity issues, including those brought forth during an FDA 483 Warning Letter. He served as a CAPA specialist as well as a technical architect to help mitigate issues in legacy systems. He served as the Global Program Manager for Software and Cybersecurity at Fisher & Paykel Healthcare, New Zealand's largest medical device manufacturer, where he was charged with ensuring cybersecurity risks are mitigated across both their ICT environment and the product portfolio. There he has successfully led a combined team of software developers and quality engineers in the development and certification of an integrated Information Security Management System that has been certified to ISO 27001 by BSI. Tyler brings a tremendous amount of experience and knowledge to our team and is excited to start helping clients navigate the ever changing cybersecurity landscape!

Workshop - Developing Medical Software according to IEC 62304