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…
ISO 14971:2019 Risk Management for Medical Devices
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.
Upcoming Events
Top-Up Training: 21 CFR Part 820 – Preparing for QMSR
Date: 22 & 23 April 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…
Regulatory Strategy – Accelerator Programme
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…
Quality Management System (QMS) – Basics – Accelerator Programme
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…
Our Services
Regulatory Consulting
Discover our comprehensive consulting services, designed to navigate the complexities of the MedTech landscape. We provide expert guidance in the following specialized areas:
- Medical Devices
- Software as Medical Device (SaMD)
- In vitro diagnostic medical devices (IVD)
Software as a Medical Device
Leverage our unique expertise in the SaMD domain. We offer specialized SaMD-related services, focused on:
- Cybersecurity
- Quality Management System
- Software Development
- Risk Management
Medical Device University
Explore the Medical Device University, a pioneering solution for online professional development. Benefit from our comprehensive e-learning platform, featuring:
- Online courses
- Course certificates
- Expert knowledge
- Comprehensive unit library
Regulatory Training
Enhance your skills and knowledge with our comprehensive training programs designed to meet the needs of the medical device industry. Our offerings include:
- Webinars
- Seminars & Workshops
Sponsor New Zealand & Australia
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.
Regulatory Monitoring
Our affordable solutions simplify regulatory monitoring, saving you time and effort as you stay abreast of the dynamic landscape. Keep pace with these services:
- Regulatory Radar
- Post Market Radar
Client Voices
“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
Updates
ISO 14971:2019 Risk Management for Medical Devices
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…
Top-Up Training: 21 CFR Part 820 – Preparing for QMSR
Date: 22 & 23 April 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…
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…
Regions
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.
Memberships
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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and to stay informed about our upcoming seminars and webinars.