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The FDA has recently released a new draft guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software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 This draft guidance…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