New Zealand’s Therapeutic Products Act 2023
In a recent and notable development, the New Zealand government has repealed the Therapeutic Products Act 2023. This Act, which received Royal Assent on July 26, 2023, was originally intended…
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Free Webinar on Machine Learning in Medical Devices (31 October)
Join us for our upcoming free webinar on Machine Learning in Medical Devices on 31 October at 11am (NZT). Tyler Harmon, an experienced expert in deep learning and machine learning,…
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Seminar PRRC – Person Responsible for Regulatory Compliance – Nov 23-24
Are you prepared for the crucial role of Person Responsible for Regulatory Compliance (PRRC) as required under EU’s MDR (2017/745) and IVDR (2017/746)? Is your organization in compliance with Article…
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FDA’s New Cybersecurity Regulations for Medical Devices: Webinar Recap
In today’s landscape of increasingly connected devices, the fusion of healthcare and technology offers transformative opportunities in patient care. However, this digital evolution also opens a Pandora’s box of cybersecurity…
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Shift Left on Security with Patient Zero – Free Cybersecurity Webinar 21 Sept
Free Webinar: Shift Left on Security with Patient Zero 21 September 2023 via Zoom Presenters: Dan Dekel, David Capper & Joe Cooney Want to dive deep into the realm of cybersecurity?…
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Workshop – Developing Medical Software according to IEC 62304 (3 August 2023)
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…
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Workshop – Medical Software Regulatory Requirements (3 August 2023)
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)…
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Free Webinar: Unpacking the FDA’s New Cyber Security Legal Requirements for Medical Devices
Do you need help understanding the new US Food and Drug Administration’s (FDA) legal requirements for cybersecurity in medical devices? We’ve got you covered. On August 17th at 11 a.m.…
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Revamping Regulation: The Imperative Shifts in New Zealand’s Therapeutic Products Bill
The Therapeutic Products Bill, promising to revolutionize the regulatory landscape for therapeutic goods in New Zealand, has stirred intense discussions among experts and industry insiders. A recent event that vividly…
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Validation vs Verification: What’s the Difference in Medical Software?
The difference between validation and verification, especially in the context of Software as a Medical Device (SaMD), can be quite nuanced and often confuses many. This is largely due to…
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