By: Robert Mueller, Chemistry Project Coordinator; Blake Northrup, Study Director; and Jason Pope, Senior Scientist Published: Medical Design Briefs When validating the steam sterilization instructions for a reusable medical device, first-time pass rates are important to manufacturers. Failures in validation testing...
By: Wendy Wangsgard, Ph.D., and Martell Winters Published: Medical Device Outsourcing What medical device manufacturers need to know about the recent changes to the ISO bioburden standard. Read More
By: Audrey Turley, Erin Bakes, and Matthew Jorgensen Published: MD+DI Here are some takeaways from ISO 19227 for orthopedic implants. ISO 19227 Implants for Surgery–Cleanliness of Orthopedic Implants–General Requirements is a long-awaited guidance document that was finalized and published early...
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