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January 2023

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Medbio Implements Cloud-Based, Quality Control and Analytics Solution

Predisys Inc., a provider of quality control and analytics software, announced that Medbio LLC, a U.S.-based, full-service medical contract manufacturer, went live with its new enterprise-wide Statistical Process Control (SPC) and Quality Data Analytics.

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 informing the organization about potential issues before they materialize. This, in turn, helps reduce process variation, improves manufacturing efficiency and lowers overall costs of quality, according to Predisys.

Medbio, headquartered in west Michigan, is a contract manufacturer offering innovative manufacturing solutions for the medical and biotechnology industries, specializing in precision injection molding, assembly and packaging. Medbio recently implemented the Predisys program in its production facility in Grand Rapids and is looking to expand to its other facilities in Michigan and New York.

"After implementing Predisys' new SPC system, we have been extremely happy with the program on a number of fronts," said Sean Callaghan, President of Medbio-Grand Rapids. "The time from project start to deployment was significantly shorter than similar projects we had previously undertaken. But more importantly, the Predisys system has empowered our personnel with real-time access to quality data to improve product quality and reduce part-to-part variability, while giving us considerable savings through more efficient inspection processes. In many cases, we have observed significant time savings when performing critical quality inspections, metrology and quality reporting tasks."

"The Predisys solutions represent a revolutionary new generation of cloud-based manufacturing solutions based on the Microsoft Azure platform, which facilitates collaboration, providing advanced analytics, automated quality processes and access to real-time information essential to product quality and process improvement," said a spokesperson. "This solution for medical device, diagnostics, biotech and pharmaceutical companies supports technical requirements of FDA Title 21 CFR Part 11 and facilitates a cost-effective, flexible and surprisingly simple transition from paper-based records to a fully automated system for electronic management of inspection and quality data records and for product and lot traceability."

"We are proud to be working with Medbio in implementing our new cloud-based SPC and quality control solution for regulated industries," said Ari Pihlajavesi, CEO and founder of Predisys. "Our close collaboration with Medbio team has helped us to bring the finishing touches to our solution so it perfectly fulfills the specific needs of this crucial industry. As a result, our solution is now faster to deploy and easier to validate. Our solution will help prevent product quality issues and recalls that can be serious and costly."

For more information contact:

Predisys, Inc.

300 Brickstone Square, Ste. 201

Andover, MA 01810


Medbio LLC

5346 36th Street SE

Grand Rapids, MI 49512


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