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Thu, 03 Aug


Callaghan Innovation

Medical Software Regulatory Requirements

Interactive workshop covering the regulatory aspects of SiMD and SaMD products supported by the HealthTech Activator and Te Tītoki Mataora

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Medical Software Regulatory Requirements
Medical Software Regulatory Requirements

Time & Location

03 Aug 2023, 9:00 am – 12:00 pm

Callaghan Innovation, 5 Sheffield Crescent, Burnside, Christchurch 8053, New Zealand

About the event

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.

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.

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