As of 1 July 2024, new regulations are in effect for all manufacturers offering cloud services in Germany’s healthcare sector. Providers must now present a C5 certification and meet strict…
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Discover how to successfully bring a medical device to market in this comprehensive 2-day introductory course by the Johner Institute New Zealand on 20 and 28 November. Designed for those…
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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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It’s done. The European Artificial Intelligence Act (AI Act) has finally become a reality. After years of back-and-forth, the time came on 13 March 2024: The European Parliament approved the…
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The introduction of the Quality Management System Regulation (QMSR) by the US Food and Drug Administration (FDA) on 2 February 2024 marks a pivotal change, as it updates the Quality…
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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In a recent and notable development, the New Zealand government has repealed the Therapeutic Products Act 2023.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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