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…
Top-Up Training: 21 CFR Part 820 – Preparing for QMSR
Discover our three distinct training programs in the field of medical device regulations: The Medical Device University, webinars, and in-person seminars and workshops. Each program offers unique opportunities to advance your skills and knowledge.
Medical Device University
Discover the Medical Device University, a cutting-edge online learning platform designed to enhance your regulatory expertise.
Webinars
Our flexible live webinars allow you to enhance your expertise from anywhere in the world.
Seminars & Workshops
Presented by industry experts, our in-person seminars and workshops provide invaluable insight into the latest regulatory trends and best practices.
Upcoming Courses
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…
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…
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…
Start Your Journey to MedTech Excellence Today!
Our premier offering, the Medical Device University, is a groundbreaking 100% online learning platform that specializes in comprehensive MedTech training. With its extensive library and a wide range of online courses, you can earn industry-recognized certificates in all medical technology-related fields, anytime and anywhere. This top-tier educational experience is designed to help you excel in the ever-evolving MedTech sector, offering unparalleled flexibility and convenience.
In addition to the Medical Device University, we also offer flexible, live webinars that allow you to enhance your expertise from anywhere in the world. These interactive courses, taught in person by experienced industry experts, cover all critical aspects of the medical device industry and ensure that you receive the most relevant and up-to-date information in the field.
For those seeking hands-on experience, our in-person seminars and workshops cover a wide range of topics including TGA, FDA and EU regulations, medical devices, IVD and software as a medical device. Delivered by industry experts, these sessions provide invaluable insight into the latest trends and best practices to keep you at the forefront of the industry.
Medical Device University
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.
Webinars, Seminars & Workshops
At the Johner Institute, we are dedicated to providing exceptional webinars and in-person seminars and workshops designed to empower professionals in the medical device, SaMD, and IVD industries. Our comprehensive training programs cover a wide range of critical topics and are tailored to meet the specific needs of our clients in Australia, New Zealand, and beyond. Explore our courses and ensure you stay ahead of the curve in the ever-evolving regulatory landscape.
Internal Auditor
Gain valuable insights into the auditing process and learn how to effectively assess compliance within your organization.
Person Responsible for Regulatory Compliance – Article 15 MDR
Master the essential responsibilities and requirements associated with this critical role in medical device companies
Quality Management System – ISO 13485
Acquire in-depth knowledge of this international standard, establishing and maintaining a robust QMS for your medical device business
Risk Management – ISO 14971
Learn the principles of effective risk management and how to apply them to your medical device products.
Software Development – IEC 62304
Understand the best practices in software development to ensure your SaMD products meet regulatory requirements and deliver exceptional performance and safety.
Cybersecurity
Enhance your cybersecurity skills with our online cybersecurity course to protect your SaMD products from cyber threats and ensure compliance with the latest regulations and best practices.
Ready to elevate your career and stay ahead in the medical device industry? Explore the best online courses and in-person seminars offered by Johner Institute New Zealand.