Having that initial brilliant idea is crucial, but it’s only the first step.

Transforming that idea into a fully developed, tested, and approved medical device with regulatory approval can be an unexpectedly long and complex process.

 

At Vestech Medical, we have a well-earned reputation for expertise in all areas of medical device development, from design and manufacture under Quality Management Systems (QMS) to successful market launch. With our extensive regulatory knowledge and first-hand experience in the approval of medical devices, our consultants de-risk investment and guide innovators to achieve regulatory compliance and approval following regulatory audits in your target jurisdictions, be they CE Mark, FDA or MDSAP jurisdictions.

If you’ve had a brilliant idea for a medical device, but are unsure as to the next steps,

then draw on the expertise of our consultants and contact us for a confidential discussion.

Your Partner in Approving Innovative Medical Devices

Vestech Medical offers tailored support to meet the needs of your unique journey. From guidance and mentoring with QMS, Regulatory, Intellectual Property (IP) and Project Management consultations through to the complete medical device development with ISO 13485:2016 certification for CE marking in the EU and FDA 21 CFR Part 820 Compliance for the US, we will provide you with the level of support you need.

 

By being proactive with our advice and considered in our approach, we will help guide you through all stages of the development process; shouldering the regulatory burden when required and giving your brilliant ideas the best opportunity to succeed.

See Our Services for more detail on the ways we can help you.

BSI ISO 13485:2016 Medical Device Logo
Quality Management System

ISO 13485:2016 Certified

Vestech Medical’s sister company, Cryptych, is the legal manufacturer of its own certified medical devices.

 

As such, the ISO 13485:2016 certification covers not only design, but also manufacture and the whole product life cycle.

Vestech Medical's CEO

Our Mission

“At Vestech Medical, our team’s decades of experience have enabled us to assist individuals in making timely and informed decisions, comprehending what lies ahead, and identifying the necessary steps to achieve optimal results and develop exceptional products.

 

Most importantly, we strive to provide our clients with a clear understanding of their destination – An approved medical device.”

Dr. Greg Roger – Vestech Medical CEO

Dr Greg Roger, FIEAust
INDUSTRY INSIGHT & CLIENT NEWS

NEWS + BLOG

  • 20 January 2023
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  • 17 January 2023
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  • CLIENT, MEDICAL DEVICES, NEWS

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Our Clients

What They Say

NSW-GOVT
NUMEDICO
RESUSRIGHT
HEADSAFE
LENEXA
AUST-GOV
SYD-UNI
Lactamo
Neuromersiv
BalanceMat
URUCU
Inventia
GYDER
MEDTECH
NUROCHEK

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

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