Qualitease

Project Summary

<aside> ⭐ This project focused on aiding the Rehabilitation Centre for Children (RCC) in Winnipeg, specifically improving their Quality Management System (QMS) for medical device compliance. Our team designed a custom web application to solve navigation difficulties and ensure regulatory compliance with ISO 13485 standards.

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The Qualitease project successfully addresses the need for a streamlined, automated compliance process. Currently, the RCC utilizes a document-heavy system that is difficult for non-technical staff to interpret. This project proposes a decision-support tool that uses interactive flowcharts and Artificial Intelligence (AI) to guide users through product verification.

Design Process

This design project required us to help a community partner streamline their documentation to allow easy interpretation of procedural flow. From the start, we aimed to make the compliance process accessible to users regardless of their technical or engineering background. We analyzed two distinct approaches to solve the problem: a Primary Action Plan (Custom Web App) and an Alternative Action Plan (Microsoft Power Apps). We explored the trade-offs between capital-intensive and labour-intensive approaches.

Key Objectives

To address the limitations of the current QMS, we established specific problem requirements to guide our design:

• Accessibility: The system must be usable by staff regardless of their technical or engineering background
• Guidance: It should provide context-aware guidance and actionable next steps during product verification
• Efficiency: The solution must centralize documentation to allow for easy interpretation of procedural flows
• Intelligence: It should provide intelligent recommendations based on historical verification data
• Feasibility: The project must be financially feasible for the client at implementation and limit ongoing management costs

Primary Action Plan (Custom Web Application)

This plan involved developing a custom web application built with a React frontend and Node.js backend, hosted on Azure. This approach focuses on creating a proprietary technology asset for the RCC. It relies on a labour-intensive development process, utilizing specialized software contractors to build a system tailored exactly to the RCC's workflow.

<aside> <img src="/icons/checkmark-line_green.svg" alt="/icons/checkmark-line_green.svg" width="40px" /> Scalable beyond 500 users, supporting long-term growth

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<aside> <img src="/icons/checkmark-line_green.svg" alt="/icons/checkmark-line_green.svg" width="40px" />

Creates a proprietary technology asset for the RCC and is tailored to their workflow.

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<aside> <img src="/icons/close_red.svg" alt="/icons/close_red.svg" width="40px" /> Labour-intensive development process requiring specialized contractors

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