As your regulatory consulting partner, we guide MedTech companies and SaMD innovators through approval in Australia, the United States, Europe, the United Kingdom, Asia, and New Zealand. You choose the approach: consulting, training, or full service.
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Global Reach
Wherever you want to launch your medical device or SaMD, we know
the regulations, the authorities, and the path to approval.
Clients
Whether you’re pre-market or scaling globally, we have the expertise to support you.
Accelerate to Market
Expand & Stay Compliant
De-Risk Investments
Services
Choose the approach that fits your team and timeline.
About Elevate MedTech
Elevate MedTech helps medical device and SaMD companies navigate the full regulatory journey, from initial classification to market access and ongoing compliance. We combine deep regulatory expertise with a practical, hands-on approach to get your device to market in your target regions.
Whether you need a strategic partner, an external PRRC, or a training programme that actually prepares your team, we deliver clarity, structure, and results.
Manufacturers established outside the EU generally need to appoint an EU Authorised Representative before placing medical devices or in vitro diagnostic medical devices on the EU market. Under the MDR and IVDR, the representative has specific regulatory responsibilities and may be jointly and severally liable with the manufacturer for defective devices under the conditions set out in Article 11(5).
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.…
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…
Our new website is live, and it’s more intuitive, easier to navigate and built around what medical device manufacturers need: information about the market you’re heading into and the stage your product has reached. Why we rebuilt it Our philosophy has always been a simple one. Getting a medical device to market is often more…
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…
