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Monthly Archives: March 2025

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Medical Devices – An Introduction to Product and Company Development in a Regulated Environment

Events & WorkshopsBy Anja SegschneiderMarch 20, 2025Leave a comment

Dates: 23 July & 29 July 2025 | 17 Sept & 25 September 2025

Top-Up Training: 21 CFR Part 820 – Preparing for QMSR

Events & WorkshopsBy adminMarch 17, 2025Leave a comment

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…

Medical Software Regulatory Requirements

Blog & Regulatory UpdatesBy Anja SegschneiderMarch 6, 2025Leave a comment

May 27, 9 AM – 3 PM NZST | Location: Callaghan Innovation, Auckland | Cost: $50 Elevate Medtech, in collaboration with HealthTech Activator, is hosting an interactive workshop on the regulatory requirements for medical software, including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). This workshop is designed for researchers…

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