What we do
At Johner Institute, we believe that clear understanding and accessibility of regulatory knowledge are crucial for the success of medical device manufacturers in bringing innovative healthcare solutions to market. Our mission is to create, share, and apply regulatory knowledge in a way that is easy to understand, enabling the development and distribution of safe, effective, relevant, and affordable medical products for the healthcare industry.
Our commitment to this mission is reflected in our fields of operation:
Regulatory Consulting
Our team provides strategic business consulting and support in maneuvering through the complex approval processes with global regulatory authorities, such as the FDA, TGA, and EU. We ensure that your medical devices adhere to all essential standards and requirements.
SaMD Expertise
We possess specialized expertise in Software as a Medical Device (SaMD) consulting, in addition to our comprehensive knowledge in all aspects related to medical devices and IVD. Our team assists clients in securing international regulatory approvals and delivering cutting-edge software solutions that adhere to industry regulations.
Quality & Regulatory Support
We offer comprehensive support to medical device manufacturers in various aspects, from developing efficient quality management systems and compliant technical documentation to conducting post-market surveillance and clinical evaluation of medical devices.
Training & Education
To share our knowledge and insights, we provide a range of training opportunities through our Medical Device University, webinars, seminars, and workshops. Additionally, our free micro-consulting services facilitate knowledge exchange within the industry, as we answer thousands of questions each year.
Research & Innovation
Our research team targets gaps in regulatory science, focusing on patient safety, device performance, and digital regulatory transformation. We produce evidence, create prototypes, and write guidelines on important topics such as IT security and AI, increasing our expertise and impact in the field.
Johner Institute New Zealand, a subsidiary of the global Johner Institute, combines local understanding with global expertise. Our firm is distinguished by our collaboration with international colleagues, which enhances our client service and provides a unique competitive advantage.
We are dedicated to empowering medical innovators with the knowledge and support they need to bring life-changing healthcare solutions to market, ultimately improving the lives of people worldwide.
What we believe
The Johner Institute was founded with a mission to improve healthcare for all. As such, our team is dedicated to generating and disseminating regulatory expertise in a user-friendly format that enables medical device manufacturers to create safe, effective, relevant and cost-effective solutions for the healthcare sector.
Our unwavering commitment to innovation, advancing future health, and knowledge has inspired us to develop a set of guiding principles that shape every aspect of our work:
- Bridging the knowledge gap: In response to the growing demand for regulatory expertise, our researchers diligently address vital questions concerning patient safety, medical device performance, digital transformation, and global MedTech challenges. Through our unwavering pursuit of excellence and innovation, we empower medical device manufacturers to navigate complex regulatory landscapes, enabling them to deliver life-changing solutions to the market.
- Making knowledge accessible: We believe in transforming complex regulatory concepts into understandable information. We’re dedicated to sharing our expertise through various channels such as articles, seminars, workshops, and our e-learning platform. Our aim is to foster a vibrant ecosystem of industry professionals who are well-versed in the latest regulatory developments and skilled in transferring knowledge to others.
- Applying our knowledge: Our team utilizes its expertise to assist medical device manufacturers in various aspects, such as quality management systems, regulatory documentation, post-market surveillance, and clinical evaluations of medical products. We are dedicated to ensuring the safety and efficacy of the devices that reach the market.
- Embracing the future: As we look ahead, we are excited to continue playing a pivotal role in shaping the future of healthcare. Our commitment to innovation and progress allows us to stay at the forefront of our industry, enabling us to better serve our clients and contribute to the advancement of medical devices worldwide.
By adhering to these principles, we aim to be a reliable ally for medical device manufacturers navigating the complex regulatory landscape, collaborating effectively to enhance the lives of patients everywhere.
Our Story
The Johner Institute New Zealand Ltd. was founded in 2021 as a subsidiary of the Johner Institute GmbH, a company with a rich history dating back to 2005. Our parent company, the Johner Institute, is headquartered in Germany with offices in Switzerland, the United States and New Zealand. This global network allows us to tap into resources and expertise from Europe, the UK, the USA, Australia, and New Zealand.
Our journey began in 2005 when the Johner Institute was established in Germany, dedicated to advancing the understanding of regulatory affairs and Software as a Medical Device (SaMD). Over the years, we have expanded our services to encompass securing international regulatory approvals and facilitating knowledge transfer through our Medical Device University, seminars, and workshops.
In 2021, we reached a significant milestone when we crossed the threshold of 100 employees and began our partnership with prestigious institutions such as Harvard University. In New Zealand and Australia, our partnerships with innovative organizations such as Callaghan Innovation, the Digital Health Association (DHA), the Medical Technology Association of New Zealand (MTANZ), Health Informatics New Zealand (HiNZ), the German-New Zealand Chamber of Commerce Inc. (GNZCC), and the German-Australian Chamber of Industry and Commerce in Australia have further enriched our knowledge and expertise, allowing us to provide cutting-edge solutions to our clients in New Zealand and Australia.
With a focus on the future, we have embraced the digital transformation of regulatory approvals, working closely with organizations such as TÜV SÜD. As a part of our commitment to continuous improvement, we have designed and launched new study programs, like “Regulatory Affairs,” and expanded our offerings in areas such as artificial intelligence (AI) and IT security.
Our Network
Leverage our industry network for enhanced services.
Certificates
As we are dedicated to stringent quality standards, our parent company has implemented a comprehensive Quality Management System (QMS) and maintained their ISO 13485:2016 certification since 2018. All of the resources we use, including the courses from the Medical Device University (MDU) and our operational templates, are developed by the Johner Institute in adherence to these rigorous standards, ensuring we deliver only the highest quality in our operations.
Regions
We can assist you with regulatory processes worldwide, including New Zealand, Australia, North America, and Europe.
