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.
The idea behind it: your journey from concept to market
The site follows the path a device takes, from its first concept and research through to ISO 13485 quality management, clinical evaluation and life on the market. You can follow the whole journey, or jump straight to the part you need. Ready to take your device into a new market and unsure where to start? Go straight to the market you’re entering. Not sure how to get your software as a medical device (SaMD) audit-ready? There’s a section for that. Our pages for markets such as Australia, New Zealand, the United Kingdom, Europe, the United States and Asia set out what each market’s medical device regulations require and how we can help, from medical device classification and technical documentation through to post-market obligations. Each page outlines the relevant regulatory pathway and authority, covering ARTG inclusion with the TGA, WAND notification via Medsafe, MHRA registration and UKCA marking, CE marking under the EU MDR, and FDA clearance in the United States. This includes the local roles overseas manufacturers may need to appoint, such as an Australian sponsor or an Authorised Representative in the European Union
Why we rebuilt it
Our philosophy has always been a simple one. Getting a medical device to market is often more manageable than people expect, and complex regulatory requirements can make it look more daunting than it needs to be. We would rather explain things in plain terms and give you what you need to make your own decisions, so you come away more capable, not more dependent on us. We wanted the new site to reflect exactly that.
A little about us
Elevate MedTech is an international medical device regulatory consultancy. We came together in 2025, when three established consultancies in the United Kingdom, New Zealand and Australia joined forces under one name, bringing more than sixty years of combined experience across medical devices, IVDs and software as a medical device. Have a look around the new site. And if you can’t find what you’re looking for, or you would just like to talk it through, get in touch.
That’s what we’re here for.
