Your innovation, brought
to life by our expertise.

We're clinical trial experts with a MedTech edge. Leveraging expertise across Australia, New Zealand, and the USA, we help innovators get off the bench and into the market.

Trusted by MedTech innovators worldwide

Mobius is an ISO 9001-certified, founder-led CRO helping innovators secure clinical and regulatory success
18
years of operational expertise
27+
therapeutic areas of experience
140+
successful trials, including 100+ in medical devices
10+
years of ISO 9001-certified quality management systems

Advancing world-first breakthroughs, faster

World first breakthroughs aren't designed to sit on the lab bench forever. They need to be in the hands of doctors and patients - saving lives and transforming outcomes. We help you get there.

Tailored services

Clinical and regulatory strategies that adapt to your pathway

Full-service model

Clinician-led expertise plus strategic partners, from pre-clinical to post-market.

Global standards

Compliance with FDA, EMA, TGA, and other regulatory bodies

The Mobius difference

Medical innovations are not one-size-fits-all, so why should your clinical trials be? At Mobius, our team uses their deep expertise to develop a clinical trial strategy tailored for you.

Traditional CRO

Rigid processes
Highly structured with little room for change
Personalized approach
Projects are tailor-made for
your needs with room to pivot
Just another client
Revolving door of project managers who
don't offer any personalization
Engaged, responsive team
Founders and project managers who embed into your team and champion your goals
Generalised MedTech Knowledge
Expertise may be lacking in
medical device trials.
Deep, niche expertise
Medical device experts from
trial design to data management

Managed 140+ clinical trial projects

Mobius helps turn your innovation into standard care

CASE STUDY

Revolutionising sperm selection with safer, stress-free technology

A new electrophoretic system offered a faster, safer alternative to conventional sperm selection. In a multicentre pivotal trial, it outperformed Density Gradient Centrifugation, matched Swim-Up, and showed no adverse events—supporting CE Mark submission.

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CASE STUDY

Early feasibility to global pivotal trial for mitral valve innovation

An innovative repositionable mitral valve system underwent early feasibility trials in Australia before scaling to a global pivotal study. Results showed durable valve function, improved survival, and quality of life—culminating in CE Mark (2020) and FDA approval (2025).

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CASE STUDY

Validating a non-invasive pain relief device for pregnancy

Pregnant women in their third trimester experienced better sleep and less pain using a specialised maternity airbed tested in a Mobius-run pilot trial. The study validated safety, comfort, and efficacy—proving a non-invasive way to ease late-pregnancy discomfort.

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"Mobius Medical have been a pleasure to work with. Their staff are reliable, they have solutions for nearly every query and have a range of experience being able to support from conception through to closeout."
“A great example of the new style of CROs – responsive, easy to work with, cost-effective, collaborative and comprehensive in all their service offerings. We could not have chosen a better partner for our investigative sites.”
"The single most crucial attribute that Mobius Medical provides is their personnel. They have staffed an incredibly skilful, competent and reliable team which is second to none. Enabling them to execute exceptionally well as an organization."

Global credibility, local mastery.

Clinical trials need to be built to scale. Our expertise ensures faster timelines, cost-effective options, and data accepted by local regulators. whether scaling early studies from Australia to the world, doing a pivotal study in the US or something in between - we transform your outcomes ensuring success.
About Mobius →

Go from clinical trials to the market with us

Our ecosystem of partners extends your reach beyond clinical trials.
Commercialization Planning
Pre-Clinical
Regulatory Strategy
Bench & Lab Testing
IP Compounding
Market Access Roadmap
Small & Large Animal Testing
Clinical Trial Supplies
Commercialization Planning
Pre-Clinical
Regulatory Strategy
Bench & Lab Testing
IP Compounding
Market Access Roadmap
Small & Large Animal Testing
Clinical Trial Supplies
Commercialization Planning
Pre-Clinical
Regulatory Strategy
Bench & Lab Testing
IP Compounding
Market Access Roadmap
Small & Large Animal Testing
Clinical Trial Supplies
Commercialization Planning
Pre-Clinical
Regulatory Strategy
Bench & Lab Testing
IP Compounding
Market Access Roadmap
Small & Large Animal Testing
Clinical Trial Supplies

Get your breakthrough
off the bench and into play.

Schedule A Call