Medical Devices – An Introduction to Product and Company Development in a Regulated Environment
Dates: 23 July & 29 July 2025 | 17 Sept & 25 September 2025
Top-Up Training: 21 CFR Part 820 – Preparing for QMSR
Date: 4 & & 10 & 16 December 2025 | Time: 3 PM – 5 PM NZT | Price: NZD 800 | Place: Online via Zoom Prepare for the transition to the new Quality Management System Regulation (QMSR) with this focused six-hour training over three days. The US FDA’s adoption of ISO 13485:2016 brings key changes…
Seminar PRRC – Person Responsible for Regulatory Compliance – Nov 23-24
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. Key…
Free Webinar: Unpacking the FDA’s New Cyber Security Legal Requirements for Medical Devices
Do you need help understanding the new US Food and Drug Administration’s (FDA) legal requirements for cybersecurity in medical devices? We’ve got you covered. On August 17th at 11 a.m. (NZST), join us for a free, one-hour webinar on “FDA Cyber Security: From Guidance to Legal Requirements”. This virtual event, conducted over Zoom, is designed…