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…
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 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…
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…
Start Date: 12 March 2025 | Cost: NZD 1,800 per month / NZD 5,400 Embark on a 3-month journey with Johner Institute New Zealand to master the intricacies of ISO 13485 and FDA 21 CFR 820 compliance through our Quality Management System (QMS) course, part of the Medical Device Accelerator programme. This immersive course is…
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 territorial requirements. Although these changes may have slipped under the radar for some, they are highly significant. It’s crucial for manufacturers interested in the EU…