In a recent and notable development, the New Zealand government has repealed the Therapeutic Products Act 2023.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 to transform the regulatory framework for medical devices, medicines and natural health products in New Zealand. However, its repeal means a return to the older…
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, will explore different types of machine learning and demonstrate their applications in medical devices. This session is designed to expand your understanding of how machine…
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 15? The understanding and implementation of these regulatory requirements is of paramount importance for every manufacturer of medical devices, regardless of their location globally. Key…
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 vulnerabilities, particularly in medical devices. Recognising this pressing issue, the US Food and Drug Administration (FDA) recently issued new regulations aimed at mitigating these risks.…
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? Want to turn theoretical understanding into pragmatic applications? Join us for a hands-on approach! On 21 September at 11am (NZST), we’re pleased to invite you…
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 by Te Tītoki Mataora and HealthTech Activator, key players in the health tech industry. Details and Location The workshop is scheduled for the 3rd of…
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) and Software as a Medical Device (SaMD) products. This comprehensive workshop is a collaboration between The Johner Institute New Zealand, HealthTech Activator, and Te Tītoki…
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. (NZST), join us for a free, one-hour webinar on “FDA Cyber Security: From Guidance to Legal Requirements”. This virtual event, conducted over Zoom, is designed…
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 encapsulated this discourse was the New Zealand HealthTech Week, where the director of the Johner Institute New Zealand, Anne Arndt, was invited to give her…
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 the fact that various regulatory bodies like the FDA, and international standards such as IEC 62304 and IEC 82304-1, may use these terms in slightly…