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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…
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.…
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…
Medical device manufacturers and sponsors operating in Australia must ensure their products meet strict regulatory standards. The Therapeutic Goods Administration (TGA) has updated its guidance in 2024 to clarify how the labelling requirements should be applied in practice. For businesses navigating the complexities of compliance, understanding these updates is essential to avoid regulatory pitfalls and…
As of 1 July 2024, new regulations are in effect for all manufacturers offering cloud services in Germany’s healthcare sector. Providers must now present a C5 certification and meet strict territorial requirements. Although these changes may have slipped under the radar for some, they are highly significant. It’s crucial for manufacturers interested in the EU…
If you plan to sell medical devices in Australia, obtaining approval from the Therapeutic Goods Administration (TGA) is a crucial step. However, if your product already has certification from a comparable overseas regulator, you can leverage this to streamline the approval process in Australia. This approach can save you significant time, effort, and money. The…
The introduction of the Quality Management System Regulation (QMSR) by the US Food and Drug Administration (FDA) signifies a pivotal shift for medical device manufacturers. As of February 2, 2024, the QMSR updates the FDA’s Quality Management System requirements under 21 CFR part 820 to align more closely with the ISO 13485:2016 standard. With the…
Conclusion The AI Act represents a monumental step in global AI legislation. While it may seem like an additional burden for many innovators wishing to bring their products to market, it’s essential to remember that similar laws will likely be introduced elsewhere. Compliance with the AI Act now could offer a competitive advantage in future…
The introduction of the Quality Management System Regulation (QMSR) by the US Food and Drug Administration (FDA) on 2 February 2024 marks a pivotal change, as it updates the Quality Management Systems requirements under 21 CFR part 820 to closely align with the ISO 13485:2016 standard. This change represents a major transition for medical device…
In a recent and notable development, the New Zealand government has repealed the Therapeutic Products Act 2023. This Act, which received Royal Assent on July 26, 2023, was originally intended to transform the regulatory framework for medical devices, medicines and natural health products in New Zealand. However, its repeal means a return to the older…
Join us for an intensive 1-day training on ISO 14971, the global standard for medical device risk management. This course is specifically designed for medical device manufacturers developing Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD) and will cover how to integrate risk management throughout the software life cycle. What…
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…
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…
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…
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,…
Start Date: 1 April 2025 | Cost: NZD 1,800 per month / NZD 5,400 Here’s your chance to fast-track your product’s market entry with Elevate Medtech’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…
Start Date: 12 March 2025 | 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…
Discover how to successfully bring a medical device to market in this comprehensive 2-day introductory course by Elevate Medtech 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 navigating regulatory requirements.…
Date: 24 April 2024 | Time: 11 AM NZT | Venue: Online via Zoom Join our online info session on 24 April at 11 am NZT to explore how our Quality Management System (QMS) course is specifically designed to accelerate your startup’s journey from concept to launch! Why Attend Our Information Event? Our online info…
Date: 17 April 2024 | Time: 11 AM NZT | Venue: Online via Zoom Join our online info session on 17 April at 11 AM NZT to explore how our 3-month Regulatory Strategy course is specifically designed to provide in-depth insights into Regulatory Strategy, pivotal for your start-up’s advancement in the medical device sector. Why…
Join us for our upcoming free webinar on Machine Learning in Medical Devices on 31 October at 11am (NZT). Tyler Harmon, an experienced expert in deep learning and machine learning, will explore different types of machine learning and demonstrate their applications in medical devices. This session is designed to expand your understanding of how machine…
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…
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…
Join us for an insightful workshop centered on the regulatory landscape of Software in Medical Device (SiMD) and Software as a Medical Device (SaMD) products. This event is jointly presented by Te Tītoki Mataora and HealthTech Activator, key players in the health tech industry. Details and Location The workshop is scheduled for the 3rd of…
Presented in collaboration by Elevate Medtech, Te Tītoki Mataora, and HealthTech Activator Join us for an intensive exploration of regulatory requirements for Software in Medical Device (SiMD) and Software as a Medical Device (SaMD) products. This comprehensive workshop is a collaboration between Elevate Medtech, HealthTech Activator, and Te Tītoki Mataora. The Opportunity and Venue Scheduled…
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…
The Therapeutic Products Bill, promising to revolutionize the regulatory landscape for therapeutic goods in New Zealand, has stirred intense discussions among experts and industry insiders. A recent event that vividly encapsulated this discourse was the New Zealand HealthTech Week, where the director of the Elevate Medtech, Anne Arndt, was invited to give her insights on…
The difference between validation and verification, especially in the context of Software as a Medical Device (SaMD), can be quite nuanced and often confuses many. This is largely due to the fact that various regulatory bodies like the FDA, and international standards such as IEC 62304 and IEC 82304-1, may use these terms in slightly…
The FDA has recently released a new draft guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”. This draft guidance proposes a novel and flexible regulatory approach for AI/ML-based medical devices, inviting public comments until July 3, 2023. A significant tool that can help in…
We are delighted to announce that Johner Institute New Zealand (JINZ) is featured on the cover of the latest issue of MedTech Outlook magazine and has been named by MedTech Outlook as a Top Medical Device Consulting Company in APAC for 2023. In the cover story, you can read about our journey since the founding…