Actis Medical offers outright
end-to-end services to bring
your medical devices to market.

Medical device approval processes for TGA, FDA, CE and others do not have to be difficult. Actis Medical are experts who undertake product design, contract and sterile manufacturing, performance and validation testing, regulatory approvals and commercialisation duties from their state-of-the-art facility.

We can act as your partner, contract manufacturer or even manage your business.

services and solutions.

Actis Medical: The difference

With 20 years of experience bringing medical devices from concept to market, Actis Medical will undertake the necessary duties required to take your medical device to market.

Your product might be a concept or it may already exist.

We understand what matters most to drive your success.

We scale our capabilities to match your needs.

what we offer.

Design and Development

Engage with our design engineers to take your product from concept through the design and development process ready for manufacturing.

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Transform your design concept from prototype into a market ready product using appropriate manufacturing methods.

We offer contract manufacturing which incorporates machining, injection moulding and advanced manufacturing processes.

Sterile manufacturing utilises our world class ISO7 clean room, sterilisation and packaging facilities.

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Validation and Performance

Regulatory Authorities such as the TGA and FDA require comprehensive performance data to approve a medical device application.  Actis Medical are experts on which tests are required and conduct the relevant ASTM / ISO mechanical performance tests in their state of the art facility.

Management of all product validation testing including biocompatibility, cleaning, packaging and sterilisation are undertaken by Actis Medical ensuring a streamlined approach.

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Quality and Regulatory

Solutions from advice to a full undertaking of responsibilities so you can use your time where it matters most.

Actis Medical is different because they will carry out your regulatory obligations.  Your company, your product and your expert partner Actis Medical at the helm of your commercialisation duties.

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Access to local and international markets.  Our specialists have a strong track record with sales distribution channels in Australia, Europe, Middle East and North Africa, SE Asia and USA.  Novel strategies such as Strategic Sourcing and a suite of product launch services are available.

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Currently Australia imports more than 80%* of its medical technology and devices. In this new COVID-19 world, there is recognised need to increase our sovereign capabilities and support commercialisation of novel IP.


partners /

Personalised Surgery
Device Technologies
Device Synergies
Paragon 28
Ortho Centric
Australian BioTechnologies
Centinel Spine
Tsunami Medical
ATi Implants Pty. Ltd.
JB Surgical
Additive Surgical
Novaeye Medical

client insights


“As a small and fast-growing company in the medical device industry, Personalised Surgery took the strategic decision to find a QMS and regulatory partner rather than build this competency in-house. It’s a minefield that we didn’t want to tackle alone, particularly given the shortage of affordable and competent people in this area. It’s hard enough keeping up with every other aspect of our business without trying to become QMS experts too. QMS and Regulatory obviously underpin everything we do, so we need to get it right. Our partnership with Actis Medical over the last 12 months has been a very positive experience. They deliver what they promise! Chris and his team are not only experts on the rules in the ever-changing space, but they provide us with strategic and cost-effective solutions to many of the regulatory and packaging issues we face. Their comprehensive on-site testing capability along with state-of-the-art clean room means increased cost control and decreased time delays. Through our relationship with Actis Medical we are getting to the places we need to go, a lot quicker and far more cost-effectively.”
– Samuel Grasso, Director and CTO, Personalised Surgery Pty Ltd


“Our start-up company faced immense challenges bringing our surgical device to market. We had invested time and money into consultancy with little result.  We thought our only option was to establish an in-house regulatory department until an industry leader suggested we speak to the team at Actis Medical. Since then, the “hands on” Actis Medical approach has seen the commercialisation of our device move quickly and efficiently. They offer a range of services unique to the market and we thoroughly recommend working with them.”
– Ben Littlejohns, Managing Director, JB Surgical.