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Free Webinar on Machine Learning in Medical Devices (31 October)

WebinarsBy Catherine Kappelle28 September 2023Leave a comment

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

SeminarsBy Annett Arndt21 September 2023Leave a comment

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

Regulatory Affairs, WebinarsBy Annett Arndt11 September 2023Leave a comment

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

WebinarsBy Annett Arndt26 August 2023Leave a comment

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)

WorkshopsBy Annett Arndt20 July 2023Leave a comment

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)

WorkshopsBy Annett Arndt20 July 2023Leave a comment

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

Seminars, Webinars, WorkshopsBy Annett Arndt11 July 2023Leave a comment

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

Regulatory AffairsBy Annett Arndt11 July 2023Leave a comment

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?

Regulatory AffairsBy Annett Arndt1 June 2023Leave a comment

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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FDA’s Draft Guidance and Webinar on AI/ML in Healthcare

Regulatory AffairsBy Annett Arndt17 May 2023Leave a comment

The FDA has recently released a new draft guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”. This draft guidance…

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