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.

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.

“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