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 the medical device arena, this three-month course is your golden ticket to navigating the complex regulatory landscape with ease. New Zealand businesses may be eligible…
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, part of the Medical Device Accelerator programme. This immersive course is your blueprint for establishing a QMS that not only meets, but exceeds the standards…
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 involved in product development and sales, business owners, founders, and CEOs, this course offers an in-depth overview of implementing a quality management system (QMS) and…
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 equip you with foundational knowledge in regulatory standards for medical software, addressing both "software as a medical device" (SaMD) and software integrated within medical devices…
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 standard, this course will guide you through understanding how to define the scope of a QMS, the core principles behind ISO 13485, and how processes…
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