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In a recent and notable development, the New Zealand government has repealed the Therapeutic Products Act 2023.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…
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.…