Hosted by the HealthTech Activator and Te Tītoki Mataora, the Medical Software Regulatory Requirements will take place in Auckland, on 26 November, 9am-3pm. This workshop will focus on the regulation requirements for medical software products, including software in, or as, a medical device.
This 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 researchers and early-stage start-up companies.
This workshop will help you understand:
- Regulatory basics including standards, guidelines, directives, laws, regulations and their interactions
- Principles of safety and performance of medical software.
- Software development processes compliant with IEC 62304 including verification and validation
- Special features of IEC 62304: The interaction between processes of development and change.
- Requirements for cybersecurity
- Market approval / clearance and ongoing changes
This will be an interactive workshop with opportunities for discussions and questions, so come ready to participate!
Who is this workshop for?
The workshop is aimed at researchers and early-stage companies who are developing medical devices that contain software (SiMD) or software as a medical device (SaMD). The content is aimed at an introductory level to support a better understanding of the regulatory aspects of SaMD and SiMD products.
This workshop is hosted in partnership by Te Tītoki Mataora | MedTech Research Translation and the HealthTech Activator.
- If you are a researcher or a clinician, please select the Te Tītoki Mataora | MedTech Research Translation ticket.
- If you are a start-up company, please select the HealthTech Activator ticket.
Event details:
- Workshop: Medical Software Regulatory Requirements (Morning tea & lunch included)
- Hosted in-person at Callaghan Innovation, Auckland
- Cost: $50 (incl. GST and booking fee)
- Attendance is limited to two attendees per company/research group.
To confirm your place please register no later than 19 November 2024. Spaces are limited, and a waitlist will open once the workshop is fully subscribed.
About the presenter:
Annett Arndt – CEO of the Johner Institute New Zealand ltd.
Anne started her career as a software developer over 20 years ago, eventually working as a consultant on software projects in the food industry. On leaving the field of software development Anne changed to quality and process management, and for the last 10 years has worked successfully on the approval of medical products in Europe.
Anne joined the Johner Institute four years ago and since then has successfully supported customers in the approval of medical devices with a focus on software as a medical device. Subsequently, Anne moved from Europe to New Zealand and together with a European manufacturer, she took advantage of the 12-hour time difference and worked with a team 24 hours a day to launch a Covid tracking app onto the market after two months of successful cooperation.
In 2021, Anne was appointed as Director of Johner Institute New Zealand, and now supports clients in New Zealand and Australia in preparing their products for global approval. Anne’s focus remains on active medical devices including software. Her passion for regulatory compliance drives her to also support suppliers to medical device manufacturers, for example helping software developers and testers to understand the development of products following a regulatory framework.
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Contact the HealthTech Activator (HTA) team for more information or explore the HTA website here.