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Predisys Inc., a global provider of quality control and analysis software, announced this Medbio LLC, a US-based full-service medical device contract manufacturer, went live with its new enterprise-wide statistical process control (SPC) and quality data analysis. The Predisys Analytical Suite, an Azure cloud-based SPC software, facilitates predictive quality control by digitizing quality records, managing them in a secure cloud environment, providing real-time access to the data with advanced analytics, and alerting the organization to potential issues before they occur they occur. This, in turn, helps reduce process variation, improve manufacturing efficiency, and lower overall quality costs.

Headquartered in West Michigan, Medbio is a contract manufacturer providing innovative manufacturing solutions to the medical and biotechnology industries, specializing in precision injection molding, assembly and packaging. Medbio recently implemented the Predisys program at its Grand Rapids manufacturing facility and plans to expand it to its other facilities in Michigan and New York.

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“After implementing Predisys’ new SPC system, we have been extremely pleased with the program in many ways,” said Sean Callaghan, President of Medbio-Grand Rapids. “The time from project initiation to delivery was significantly faster than similar projects we’ve had. But more importantly, the Predisys system has given our staff real-time access to quality data to improve product quality and reduce part-to-part variability reduce while we have achieved significant savings through more efficient inspection processes. We have seen significant time savings in performing critical quality inspection, metrology, and quality reporting tasks.”

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Predisys solutions represent a revolutionary new breed of cloud-based manufacturing solutions built on the Microsoft Azure platform that facilitates collaboration, advanced analytics, automated quality processes and access to real-time information essential to product quality and process improvement . Supporting the technical requirements of FDA Title 21 CFR Part 11, their offering for medical device, diagnostics, biotech, and pharmaceutical companies facilitates a cost-effective, flexible, and surprisingly easy transition from paper-based records to a fully automated system for electronically managing inspection and quality data records, as well as for traceability of products and batches.

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“We are proud to partner with Medbio on the implementation of our new cloud-based SPC and quality control solution for regulated industries,” said Ari Pihlajavesi, CEO and Founder of Predisys. “Working closely with the Medbio team has helped us fine-tune our solution to perfectly meet the specific needs of this important industry. As a result, our solution is now faster to deploy and easier to validate. Our solution will help avoid product quality issues and product recalls, which can be serious and costly.”


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