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:
Are you prepared for the crucial role of Person Responsible for Regulatory Compliance (PRRC) as required under EU’s MDR (2017/745) and IVDR (2017/746)? Is your organization in compliance with Article 15? The understanding and implementation of these regulatory requirements is of paramount importance for every manufacturer of medical devices, regardless of their location globally. …
In today’s landscape of increasingly connected devices, the fusion of healthcare and technology offers transformative opportunities in patient care. However, this digital evolution also opens a Pandora’s box of cybersecurity vulnerabilities, particularly in medical devices. Recognising this pressing issue, the US Food and Drug Administration (FDA) recently issued new regulations aimed at mitigating these risks.…
Free Webinar: Shift Left on Security with Patient Zero 21 September 2023 via Zoom Presenters: Dan Dekel, David Capper & Joe Cooney Want to dive deep into the realm of cybersecurity? Want to turn theoretical understanding into pragmatic applications? Join us for a hands-on approach! On 21 September at 11am (NZST), we’re pleased to invite you…
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.
