If you plan to sell medical devices in Australia, obtaining approval from the Therapeutic Goods Administration (TGA) is a crucial step. However, if your product already has certification from a…
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The introduction of the Quality Management System Regulation (QMSR) by the US Food and Drug Administration (FDA) signifies a pivotal shift for medical device manufacturers. As of February 2, 2024,…
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Date: 24 April 2024 | Time: 11 AM NZT | Venue: Online via Zoom Join our online info session on 24 April at 11 am NZT to explore how our…
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Date: 17 April 2024 | Time: 11 AM NZT | Venue: Online via Zoom Join our online info session on 17 April at 11 AM NZT to explore how our…
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We are delighted to announce that Johner Institute New Zealand (JINZ) is featured on the cover of the latest issue of MedTech Outlook magazine and has been named by MedTech…
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In a recent and notable development, the New Zealand government has repealed the Therapeutic Products Act 2023.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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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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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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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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