The Johner Institute’s Medical Device University offers a rare opportunity to expand your regulatory knowledge at your own pace, anytime, anywhere. Our online courses offer expert knowledge and course certificates in areas such as regulatory affairs, quality management systems, risk management, or software as a medical device.
With a comprehensive unit library and access to the latest information from regulatory agencies including FDA, TGA, EU and MHRA, our online courses are the perfect solution for professionals who want to stay on top of the latest developments in the field. Enroll in our online courses today and gain the knowledge and skills you need to succeed in the fast-paced world of medical technology.
– Make your winter count! We’re offering 12 months’ access for the price of 10! The warm season ist ending, and now’s the perfect time to get productive and sharpen your medical device knowledge. Valid until 31 May. –
Start Date: 10 September 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…
Start Date: 13 August 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…
Date: 15 & 16 July 2025 | Time: 1:00 PM – 5:00 PM NZT (Half-Day Sessions) | Price: NZD 800 | Place: Online via Zoom Prepare for the transition to the…
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…
Date: 9 & 10 April 2025 | 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…
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…
Discover our comprehensive consulting services, designed to navigate the complexities of the MedTech landscape. We provide expert guidance in the following specialized areas:
Leverage our unique expertise in the SaMD domain. We offer specialized SaMD-related services, focused on:
Explore the Medical Device University, a pioneering solution for online professional development. Benefit from our comprehensive e-learning platform, featuring:
Enhance your skills and knowledge with our comprehensive training programs designed to meet the needs of the medical device industry. Our offerings include:
We act as the responsible person for overseas manufacturers in New Zealand & Australia, expertly guiding international MedTech companies through the local regulatory process and ensuring compliance with New Zealand & Australian requirements.
Our affordable solutions simplify regulatory monitoring, saving you time and effort as you stay abreast of the dynamic landscape. Keep pace with these services:
“The expertise and meticulous approach from Johner Institute has been nothing short of excellent. With an unparalleled understanding of both national and global regulations, they crafted a framework that not only navigates intricate regulatory landscapes but also ensures our products meet the highest safety standards.”
— Simon Barnett | Head of Training Hato Hone St John | Aotearoa New Zealand
“We solicited services from Anne early in our development journey for a product that has cloud services, firmware, and software. We have found her depth of knowledge, provision of resources and ability to quickly get across what we’re doing to be fantastic. We highly recommend working with Anne and her team.”
— Emma Hayes | Chief Operating Officer, Swaltech
“After several successful projects with the Johner Institute, the one thing that truly stands out for me, besides their professionalism and expertise in the regulatory domain, is how they always put people over processes. Especially in a field where rigidity and long waiting times are the norm, receiving quick, competent feedback even only on small questions really can make a huge difference.”
— Hannes Seibt | Pentax Medical
Internal audits are not just a regulatory formality, they are a cornerstone of any effective quality management system. Required by international standards such as ISO 13485 and FDA’s 21 CFR…
Start Date: 10 September 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…
Start Date: 13 August 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…
At the Johner Institute, we help medical device manufacturers navigate the complex regulatory landscape in New Zealand, Australia, North America and Europe. Our experienced team will guide you through the FDA, TGA, Notified Bodies, and CE Marking processes to ensure your product reaches the market efficiently and compliantly. Trust us to be your partner in the successful launch of medical devices in these key regions.
Discover the benefits our valued memberships and cooperations provide to our clients, enhancing our services through a strong network of industry connections and expertise.
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