Medical Device Maker Avoids Shutdown, Achieves Full FDA Clearance with No Failures
Medical Device Maker Avoids Shutdown, Achieves Full FDA Clearance with No Failures
4 PagesClient A manufacturer of complex and highly engineered implantable medical devices. Challenge Two defects were discovered during in-house testing with no indication of what was causing the defects or when they had begun. To prevent in-field complications, the company stopped shipping the device for several months as a kaizen team studied the root causes of the defects and corrected them. Solution Intensive process mapping of changes in
