Device Risk Classification Prototype

Engage with Zuhlke to redefine the experience of clients enquiring on the risk classification for potential new medical devices. The goal of this offer is to assess the feasibility of AI/ML technology to help to automatically classify device risk accurately, reduce manual processing time, explain classification logic transparently, and provide a feasibility assessment on whether it can evaluate and improve the process in the long-term.

Zuhlke will provide its expertise in defining an approach and framework for a detailed discovery workshop and prototype development phase, and based on Zuhlke's capability to develop bespoke AI/ML solutions, while customers will contribute industry and domain know-how, data of suitable quality and volume, as well as project steering and guidance.

The expected outcome is a high-quality prototype that assesses the feasibility of reducing the complexity and time associated with the current process. Zuhlke will evaluate which portions of the Device Risk Classification process can be supported by AWS Data and AI/ML technologies.

This marketplace offer will be particularly useful for government medical device regulators and bodies, as it can lead to a more interactive and efficient system for future end-users, potentially incorporating a self-service element.

This offer is only applicable to clients in Asia.