Medical Devices – An Introduction to Product and Company Development in a Regulated Environment
Dates: 23 July & 29 July 2025 | 17 Sept & 25 September 2025
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Top-Up Training: 21 CFR Part 820 – Preparing for QMSR
Date: 4 & & 10 & 16 December 2025 | Time: 3 PM – 5 PM NZT | Price: NZD 800 | Place: Online via Zoom Prepare for the transition to the new Quality Management System Regulation (QMSR) with this focused six-hour training over three days. The US FDA’s adoption of ISO 13485:2016 brings key changes…
Medical Software Regulatory Requirements
May 27, 9 AM – 3 PM NZST | Location: Callaghan Innovation, Auckland | Cost: $50 Johner Institute New Zealand, in collaboration with HealthTech Activator, is hosting an interactive workshop on the regulatory requirements for medical software, including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). This workshop is designed…
ISO 14971:2019 Risk Management for Medical Devices
Date: Two consecutive days, to be advised | Time: 11:00 AM – 3:00 PM NZT (Two Half-Day Sessions) Cost: NZD 950 | Format: Online Master the fundamentals of ISO 14971:2019 and its impact on medical device risk management. This course is designed to provide a comprehensive understanding of how risk management applies to the design,…
Medical Device Labelling in Australia: What Manufacturers and Sponsors Need to Know
Medical device manufacturers and sponsors operating in Australia must ensure their products meet strict regulatory standards. The Therapeutic Goods Administration (TGA) has updated its guidance in 2024 to clarify how the labelling requirements should be applied in practice. For businesses navigating the complexities of compliance, understanding these updates is essential to avoid regulatory pitfalls and…
Regulatory Strategy – Accelerator Programme – April
Start Date: 1 April 2025 | Cost: NZD 1,800 per month / NZD 5,400 Here’s your chance to fast-track your product’s market entry with Johner Institute New Zealand’s cutting-edge Regulatory Strategy Course. Designed for medtech professionals and newcomers looking to make their mark in the medical device arena, this three-month course is your golden ticket…