Services designed around your pathway

Clinical trials aren't one size fits all. This is why Mobius tailors strategies and services to your device while meeting global standards.

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How we support your trials

Our services cover the full pathway, from feasibility through to post-market.
You can work with us end-to-end or just where you need us most.

Clinical Trial Strategy

We design studies that are tailored to your goals and budget, while ensuring critical physician interactions to accelerate success.

Idea Conception • Design & Planning • Physician Interface
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Clinical Trial Execution

We manage your studies end-to-end keeping your program moving and delivering inspection-ready data.

Trial Startup & Management • Data Analysis & Reporting
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Regulatory and Beyond

Align your trial with global regulatory standards built into the strategy from day one.

Regulatory Planning • Quality Assurance and Compliance
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The highest standard of delivery

Every service is delivered to go above and beyond on compliance and quality.
ISO-9001
ISO certified QMS. Our systems ensure trials are inspection-ready at all times.
ICH GCP / ISO-14155
ISO aligned data. Outputs regulators accept worldwide (FDA, EMA, TGA).

140+ trials
Supported devices across 27+ therapeutic areas.

More than a CRO. Your MedTech ecosystem.

Every founder has a different starting point. Whether your priority is raising investment, validating feasibility or achieving FDA approval, Mobius builds a pathway tailored to you.

Ensuring your innovation reaches doctors and patients

  • Regulatory Strategy
  • Reimbursement Strategy
  • Market Access Roadmap
  • Intellectual Property Road mapping
  • Funding and M&A
  • Post-Market Surveillance
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Generate preliminary evidence and a clear pathway to human trials

  • Bench & Lab Testing
  • Small & Large Animal Testing
  • Cadaver (Wet) Lab Testing
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Build a product ready for launch and scaling

  • Product Development & Design
  • Prototype & Small Batch Manufacturing
  • Technical File Development
  • Clean Room & Equipment Hire
  • MVP & Design Lock
  • Scale-Up
  • Clinical Engineer Support
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Ensure regulatory compliance and engagement across the globe

Regulatory Agency Strategy, engagement & Submission

  • Q-Sub/Pre-Sub
  • Conformity Assessment
  • 13485, 21 CFR 820 QMS Set-Up & Management
  • Audits & Quality Assurance
  • SOP & Document Development
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Get everything you need for a seamless trial

  • Pathology Kits
  • Core Labs
  • Imaging
  • Logistics
  • IP Storage & Distribution
  • IP Compounding
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Bolster your go-to-market strategy with clarity

  • Medical Policy & Coverage Research
  • Payer Research & Gap Analysis
  • Coding & Billing
  • Health Economics
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Commercialization and Post-Launch

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Pre-Clinical

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Design and development

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Regulatory and Quality

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Clinical trial supplies

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Reimbursement

What partners say about us

Our track record is best told by the founders and clinicians we’ve worked with.
“At the time of data-lock for an upcoming CE Mark submission, Mobius was able to get ahead of monitoring which resulted in a timely CE Mark submission.  I have worked with CROs around the world and have really enjoyed the relationship.  They are just great people and partners.”
“Mobius Medical is a great example of the new style of CROs – responsive, easy to work with, cost-effective, collaborative and comprehensive in all their service offerings from monitoring to e-solutions for patient recruitment. Cardiac Dimensions could not have chosen a better partner for our investigative sites in Australia and New Zealand.”
“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. The Directors of Mobius each have unique credentials, experience and talents, which together with their team, enable them to execute exceptionally well as an organization”
“Running such a critical clinical trial in Australia from the United States West Coast was an anxious prospect for us and so we were glad to partner with a company that understood our needs.”
“Mobius personnel have been responsive and professional with a clear demonstration of their experience conducting high quality research in compliance with applicable regulations and guidance.”
“[Mobius] have shown their ability to engage and maintain excellent working relationships with site personnel to ensure that work is completed accordingly to Sponsor deadlines”
“Selecting this team [Mobius] for the job was an inspired choice”
“We found Mobius to be a streamlined, agile company that were prepared to go above and beyond what was expected of them”
“Through fantastic site management, Mobius was able to close and lock the study in record time, a crucial factor in the success of our company”
"I have not received any [costing]‘surprises’ outside the quotation for works”
“Mobius Medical has performed monitoring, project management, have built a clinical databases and are a 'go to' expert in the clinical research field. They have been an extreme pleasure to work with, and our sites like working with them, too.”
“Mobius Medical has a clear understanding of clinical research and the regulatory bodies. Their monitoring has been thorough and is always up to date, they have tactfully addressed hard enrolment questions with sites, while developing professional long-standing working relationships, and have kept the projects on track. I trust working with Mobius Medical and look forward to working on future projects with them”

Guiding you through what you don’t know yet

We answer the questions you may not even know to ask, from readiness to cost, timelines to regulatory differences, so you can move forward with clarity.

How do I know if I’m ready for a clinical trial?

If you’ve completed your prototype, generated pre-clinical data based on a robust risk analysis plan, and defined your intended use, you’re likely ready to explore a first-in-human or feasibility study. We can assess your device, documentation, and regulatory pathway to confirm readiness and define the next steps.

Why start in Australia?

Australia offers globally recognised ICH-GCP/ISO 14155-compliant standards, rapid ethics and regulatory approvals, and generous R&D tax incentives—up to 43% cashback on eligible spend. Data collected here are widely accepted by international regulatory authorities, making it the ideal place to start.

How much does a trial cost?

Budgets vary by study size, endpoints, and number of sites. Early feasibility studies with full-service typically range from AUD $250K–$1M; pivotal studies are higher. We tailor budgets to your design and help identify tax and funding offsets.

What’s the fastest way to get FDA approval?

Running early feasibility or safety studies in Australia allows you to collect high-quality data quickly, which can be used in your FDA IDE or 510(k) submission. This “ANZ-to-US bridge” is one of the most time-efficient routes to market.

What’s different about MedTech vs Pharma trials?

Medical device trials focus on performance and safety, not drug pharmacokinetics. They’re usually smaller, faster, and more iterative—requiring deep technical and engineering understanding as well as clinical rigour. Focus is on safety and feasibility of the application or procedure, technical training and user experience whereas in drug trials, controlled exposure for safety and efficacy are paramount.

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