CRYPTYCH - MEDICAL DEVICE. INNOVATION & 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.

CRYPTYCH OFFERS SUPPORT FOR THE FOLLOWING MEDICAL DEVICES

PRECISION SCREW

The Precision Screw

The Precision Screw is an implantable grade metallic bone screw designed to be implanted into cortical bone of vertebrae. This provides physicians with a tool to assist in the electromagnetic tracking of instruments with respect to pre-acquired or real-time image data.

To suit a wide breadth of use cases, the Precision Screw is available in 2 sizes which includes straight or tapered thread variant and is supplied sterile. The Precision Screw is MR safe.

PRECISION SCREW DRIVER

The Precision Screw Driver

The Precision Screw Driver is intended to drive the Precision Screw into the vertebral cortical bone. The reusable Precision Driver is manufactured from biocompatible materials and requires no servicing  or disassembly prior to reprocessing.

The Precision Driver is available in 2 sizes to suit the Precision Screw catalogue range only and should only be stored using the Precision Tray.

PRECISION TRAY

The Precision Tray

The Precision Tray is intended to provide a safe location in which to store the sterile Precision Screws and Precision Screw Drivers during surgery. The Precision Tray is the only approved accessory to facilitate engagement of the Precision Screw.

The Precision Tray is available in one configuration to suit all Screw and Driver variants and is also used to provide a holding location for the Precision Driver during reprocessing.

QUALITY MANAGEMENT SYSTEMS

QMS IS AT THE CORE OF WHAT WE DO

Cryptych is certified to ISO 13485:2016 and is FDA Compliant (21 CFR Part 820), enabling us to comprehensively meet the rigorous regulatory requirements for all stages of medical device development.

BSI ISO 13485:2016 Medical Device

MEDICAL DEVICE. INNOVATION

Vestech is Cryptych’s Medical Device Innovations 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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