The Johner Institute is an international leader in regulatory compliance consulting for medical devices, software as a medical device (SaMD), and in vitro diagnostic medical devices (IVD). We assist you in launching your products swiftly and seamlessly in New Zealand, Australia, North America, and Europe, ensuring a smooth market entry.
Rely on our experts to help you navigate regulatory challenges, or access our digital Medical Device University, online courses, seminars, workshops, and blog articles to gain valuable knowledge.
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:
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…
Embark on a 6-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,…
Discover how to successfully bring a medical device to market in this comprehensive 2-day introductory course by the Johner Institute New Zealand on 20 and 28 November. Designed for those…
The Johner Institute New Zealand, in collaboration with Te Tītoki Mataora and HealthTech Activator, is pleased to present the "Medical Software Regulatory Requirements" workshop in Auckland. This hands-on workshop will…
This 1-day course provides a comprehensive introduction to ISO 13485, the international standard for quality management systems in the medical device industry. Instead of focusing on individual sections of the…
“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
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…
Discover how to successfully bring a medical device to market in this comprehensive 2-day introductory course by the Johner Institute New Zealand on 20 and 28 November. Designed for those…
If you plan to sell medical devices in Australia, obtaining approval from the Therapeutic Goods Administration (TGA) is a crucial step. However, if your product already has certification from a…
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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