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 require resolution, adding to the total validation time, which can result in a delay to a regulatory submission, getting a device to market, or both. Read the full article on the MDB website.