Transforming brilliant ideas
into medical devices

Vestech
Medical Device. Innovation

VESTECH - MEDICAL DEVICE. INNOVATION

With a dedicated and highly experienced team, a streamlined process with clear and effective pathways to market, Vestech delivers the complete device development solution.

QUALITY MANAGEMENT SYSTEMS

QMS IS AT THE CORE OF WHAT WE DO

With Cryptych, our Regulatory & Compliance division, we are able to ensure ISO 13485:2016 and FDA Compliance (21 CFR Part 820), enabling us to comprehensively meet the rigorous regulatory requirements for all stages of medical device development.

BSI ISO 13485:2016 Medical Device

STREAMLINED PROCESS

Our Cryptych QMS and streamlined development process ensures an efficient and cost effective pathway to market. Our successful development process includes the following key pillars.

PROJECT MANAGEMENT

Vestech is able to take your device from the initial concept through all stages of device development to market delivery with a wealth of experience, proven process, and dedicated resources. Throughout the process, Vestech employs a defined strategy to ensure all vendors align with your specific goals and that your device is compliant with the relevant standards to meet regulatory requirements.

CLINICAL RESEARCH

Clinical research is often required to develop sufficient clinical evidence to comply with regulatory requirements. This requires an understanding of the medical device, its design/risk profile, and the clinical need for the device. Vestech brings engineering, medical, and project management control to prudently manage all Clinical Research Organisation (CRO) activities and deliver the required clinical evidence.

IP STRATEGY

A sound Intellectual Property (IP) Strategy is more than just filing a patent. Using IP as a commercial strategy requires a complete understanding of market drivers, other commercial entities in the space, and the changing nature of the market and technology landscape. Vestech ensures you are well informed to enable you to employ the most secure and cost-effective IP Strategy in the development of your device.
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Our Clients

What They Say


Excellent clarity in a complex area. Very suited to companies trying to find their way, and extremely personable at the same time.

REBECCA CROFT
Managing Director, Croft Associates

Dr Roger was a pleasure to work with in his role as the Medical and Scientific Technologies Supplier Advocate during 2013-14. He was professional, innovative, enthusiastic and passionate about achieving practical outcomes to drive the sustainable growth of the medtech sector.

KYLIE CLARK
Senior Policy Officer, Department of Industry

Greg Roger brings an incredible breadth of experience & knowledge to the table – engineering, patents, regulatory, medical devices, surgery. And this knowledge is of the first-hand, hard-won variety. What this means is that Greg’s advice tends to be extremely practical and useful.

ROGER PRICE
CEO, ResQ Devices

Vestech provided invaluable advice on our commercialistion strategy. Their advice prevented loss of scarce time and capital, and alerted us to risks we would face in the future. Our time with Vestech has been critical for our success to date.

GARY VERDICKT
Director, Senver Pty Ltd

Contact Vestech to schedule a time to discuss your device ideas.

CONTACT
ABOUT. VESTECH

At Vestech we believe in partnering with you. By being proactive with our advice and considered in our approach, we are able to help guide you through all stages of the development process; shouldering the regulatory burden and giving your brilliant ideas the best opportunity to become market available devices. [read more]

QUALITY MANAGEMENT
ISO-13485:2016

With Cryptych, our Regulatory & Compliance division, we are able to ensure ISO 13485:2016 and FDA Compliance (21 CFR Part 820).

CONTACT. VESTECH

Suite 1502
275 Alfred Street
North Sydney NSW 2060
Australia
Tel: +61 2 9959 5820

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