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Medbio receives ISO 13485 certification

April 17, 2018 By Danielle Kirsh

medbio Medbio announced that it has received its certificate for the 2016 revision of the ISO 13485 standard. The certification helps the company upgrade its quality management system.

“We are pleased to have achieved this milestone,” says Joe Szyperski, VP of quality and regulatory affairs for Medbio (Grand Rapids, Mich.). “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.”

Medbio currently specializes in cleanroom injection molding, assembly and packaging for the orthopedic, cardiovascular, ophthalmology, neurology and biotechnology OEM markets.

About The Author

Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at dkirsh@wtwhmedia.com.