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.