Medbio LLC, a US-based Full-Service Medical Contract Manufacturer, Implements Predisys’ Azure Cloud-Based, Quality Control and Analytics Solution for the Medical Device and Biotech Industries

Predisys Inc., a global provider of quality control and analytics software, announced that Medbio LLC,  a U.S.-based, full-service medical contract manufacturer, went live with their 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.

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 their production facility in Grand Rapids and is looking to expand to their 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.  Their offer 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.”



Predisys specializes in developing quality control, data management, and analytics software solutions which enable manufacturers to make informed decisions that will improve product quality, increase productivity, and positively impact the bottom line. Their unique combination of on-demand quality data analytics and enterprise-grade SPC in one solution helping manufacturing, quality and product engineering teams proactively identify and prevent quality issues. Predisys was founded in 1996 in Finland and their solutions have been employed in manufacturing plants across North America, Europe, and Asia. The company operates in U.S. with an office in Andover, MA, as well as in Finland. For more information, please visit

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