“Our streamlined and proven process offers clear and effective pathways to market. It gives your brilliant ideas the best opportunity to become market available medical devices”.

Dr. Greg Roger – Vestech CEO

PARTNERS IN INNOVATION

At Vestech we believe in partnering with you. We shoulder the regulatory burden and give your brilliant ideas the best opportunity to become market available medical devices.

DELIVERING ON YOUR INVESTMENT

When it comes to investment opportunities, Vestech believes in being both prudent and accountable. This, as well as Vestech’s wealth of experience, enables us to deliver on your investment.

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.

MEDICAL DEVICE INNOVATION

PROJECT MANAGEMENT

By managing every stage of development in-house, our Cryptych QMS and streamlined development process ensures compliance, as well as the most efficient and cost effective pathway to market.

: ASSESSMENT & STRATEGY

In the early stages of your medical device, Vestech offers a brief overview of the development path ahead. This may include an overview of the likely timelines, activities needed, and the likely expense of each stage for these activities. Following this, Vestech offers you support for the development of the appropriate strategy to achieve success.

: DESIGN & ENGINEERING

Vestech has experienced designers and engineers and engages the appropriate external design houses to execute this aspect of your project. There are many phases of the design and development process. Vestech ensures that your product meets regulatory and market requirements.

: PROTOTYPING

Vestech has a network of prototyping partners, who may be employed throughout the development phases of your project. Vestech utilises appropriate and cost-effective prototyping partners matched to your phase of development.

: MANUFACTURE

Manufacturing is considered by Vestech early in the project to engage the appropriate manufacturing facilities and ensure compliance with the relevant standards. Additionally, early engagement of manufacturing facilities streamlines the transfer of the manufacture process to the facilities when the time comes. Vestech appoint, audit, and control these manufacturers to ensure the highest standard outcome.

: CLINICAL TRIALS

In most cases, clinical trials are undertaken complementary to clinical research. This task requires a complete and in-depth 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 CRO activities.

: REGULATORY COMPLIANCE

Without Regulatory Compliance there is no route to market for medical devices in most parts of the world. Regulatory Compliance is achieved through compliance with Quality Management Systems. Vestech works diligently with you and the appointed partners to achieve Regulatory Compliance in a timely fashion.

CONTACT VESTECH MEDICAL

INDUSTRY INSIGHT & ANALYSIS

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.