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 Management Systems requirements under 21 CFR part 820 to closely align with the ISO 13485:2016 standard. This change represents a major transition for medical device…
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 12-month Quality Management System (QMS) course is specifically designed to accelerate your startup’s journey from concept to launch! Why Attend Our Information Event? Our online…
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 3-month Regulatory Strategy course is specifically designed to provide in-depth insights into Regulatory Strategy, pivotal for your start-up’s advancement in the medical device sector. Why…
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 Outlook as a Top Medical Device Consulting Company in APAC for 2023. In the cover story, you can read about our journey since the founding…
In a recent and notable development, the New Zealand government has repealed the Therapeutic Products Act 2023.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…