CRYPTYCH - MEDICAL DEVICE SUPPORT

With a dedicated and highly experienced team, a streamlined process with clear and effective pathways to market, and a comprehensive regulatory and support framework, Cryptych delivers the complete device development solution.

QUALITY MANAGEMENT SYSTEMS

QMS IS AT THE CORE OF WHAT WE DO

Cryptych has a Quality Management System meeting the requirements of ISO 13485:2016, 21 CFR Part 820 and EU MDR 2017. This enables us to comprehensively meet the rigorous regulatory requirements for all stages of medical device development.

MEDICAL DEVICE INNOVATION

Cryptych is Vestech’s medical device manufacturing division. Their proven QMS and streamlined development process ensures an efficient and cost effective pathway to market. Vestech’s 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.

CONTACT CRYPTYCH FOR MEDICAL DEVICE SUPPORT

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