TRANSFORMING BRILLIANT IDEAS
INTO MEDICAL DEVICES

VESTECH MEDICAL PARTNERING WITH YOU

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

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.

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.

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.

VESTECH NEWS

08/04/2022
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CRYPTYCH, MEDICAL DEVICES, VESTECH

ISO 13485 Audit Passed 2022

Cryptych P/L, Vestech’s sister company, recently passed its annual ISO 13485 audit, carried out by notified body BSi. This pass was...

27/01/2021
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MEDICAL DEVICES, VESTECH

Sydney University & Vestech develop TGA cleared emergency ventilators

At the beginning of the Covid19 pandemic Sydney University was engaged by the NSW Department of Health to develop an emergency...

20/07/2019
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PRESS RELEASES, VESTECH

What drives one doctor-turned-engineer to keep innovating

In surgery as well as engineering, Greg Roger understands why precision matters in innovation. Dr Greg Roger aspired to be a surgeon,...

MORE NEWS

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.