Prime Path Medtech™ - Modernization of Quality Management System

Breanne Butler | Project manager at Prime Path Medtech™

‘‘We are quite satisfied with the Cleveroad team and our collaboration so far. We especially appreciate how they maintained the communication. The team was constantly in touch with us and available at each step of the process.’’

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Prime Path Medtech™ provided its clients with services via a legacy Quality Management System (QMS). It was built on Quickbase, outdated, inflexible, inefficient, and didn't fit the B2B business model. Our customer needed a fully automated QMS covering all processes and documentation flow of the company's clients.

Goals set to Cleveroad

• Replace the obsolete Quickbase-built QMS with an automated system providing transparent workflow, user-friendly UI, and efficient UX
• Integrate the new QMS with the customer’s Quality control services, retaining all processes, functions, and roles needed for medical devices’ certification
• Scale business, level up revenue indicators and customer satisfaction rate staying within a limited budget

Solutions we've delivered

• From-scratch-creation of a flexible QMS within the B2B SaaS business model. Providing the customer with end-to-end services, including full-cycle software development, consulting, business analysis, and project management
• Development of the QMS architecture and modules, considering the whole business context, workflow, and compatibility with FDA 21 CFR 820 and 21 CFR 11 and the ISO 13485 requirements
• Development of the entire system by our in-house team, abandoning the Quickbase. Creating an automated platform to reduce manual operations and free up labor. Simplify the system’s workflow to level up user satisfaction

Results for the Customer

• The QSuite, a flexible, responsive web-based QMS, was successfully designed and developed. Now the company’s clients use the system, giving positive feedback about its convenience, flexibility, and functionality
• Our system is successfully integrated into the company's services. Using it allows manufacturers to meet the FDA and ISO certification requirements for medical devices and their production
• Reduced overhead costs for our customer and its end clients (manufacturers). Increased competitiveness due to lower price of B2B SaaS usage. Enhanced user satisfaction thanks to an intuitive UI/UX and processes automation