Medical device compliance is rarely the problem in theory. The challenge is making ISO 13485 and regulatory requirements work in real companies, with real products, limited time, and competing priorities. That’s exactly why we’ve launched Quality and Regulatory Compliance for Medical Device Manufacturers, a tailored, one-on-one training service designed to build practical, audit-ready capability inside your…
Are you ready for the QMSR? FDA’s new Quality Management System Regulation (QMSR) lands in February 2026 and it will raise the bar by aligning more closely with ISO 13485. If your system has grown up around 21 CFR 820, the big question is simple: have you already covered the key differences — or are there gaps hiding…
We’re excited to be part of Innovate Western Sydney 2025 — a one-day event that brings together health innovators, tech leaders, founders, and researchers to explore what’s next for Western Sydney’s thriving innovation ecosystem. Taking place on 25 November at the Westmead Innovation Centre, the event features panels, startup pitches, breakout tours, and plenty of chances to connect — including…
Start Date: 3 February 2026 | Cost: NZD 1,800 per month / NZD 5,400 Here’s your chance to fast-track your product’s market entry with Elevate Medtech 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…
Start Date: 4 March 2026 | Cost: NZD 1,800 per month / NZD 5,400 Embark on a 3-month journey with Elevate Medtech 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…
Internal audits are not just a regulatory formality, they are a cornerstone of any effective quality management system. Required by international standards such as ISO 13485 and FDA’s 21 CFR Part 820.22, and expected under European regulations like MDR and IVDR, internal audits help organisations stay compliant, avoid costly errors, and continuously improve their processes.…
Dates: 23 July & 29 July 2025 | 17 Sept & 25 September 2025
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…
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…
Date: Two consecutive days, to be advised | Time: 11:00 AM – 3:00 PM NZT (Two Half-Day Sessions) Cost: NZD 950 | Format: Online Master the fundamentals of ISO 14971:2019 and its impact on medical device risk management. This course is designed to provide a comprehensive understanding of how risk management applies to the design,…