Medbio is pleased to announce they have received their certificate for the 2016 revision of the ISO 13485 standard. This certification is the culmination of a year-long effort to upgrade their Quality Management System, and better positions Medbio to serve its broad customer base going forward.
“We are pleased to have achieved this milestone,” says Joe Szyperski, V.P. of Quality and Regulatory Affairs for Medbio. “The whole team is adopting risk-based thinking, a theme of the new standard, which is important given the ever-increasing regulatory demands of our industry.”
About Medbio, Inc.
Medbio (www.medbioinc.com) is an ISO 13485:2016-certified medical contract manufacturer, specializing in clean room injection molding, assembly, and packaging, with clients based throughout the U.S., Europe, and Central America. Medbio is currently building products for the orthopedic, cardiovascular, ophthalmology, neurology, and biotechnology OEMs. Medbio has posted 13 years of growth, been honored as an Edward Lowe “Michigan 50 Companies to Watch,” and recognized in the Inc. 5000 list of fastest-growing private companies in America. Follow us on Facebook and LinkedIn.
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