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EOL Design Changes and DHF Remediation

Case Study

This global leader in medical device manufacturing inherited this medical device as part of an acquisition. The device had previously been in production for roughly 20 years and the client was the fifth owner of the device. This made for a large convoluted mix of documentation to account for the Design History File (DHF). The client knew a solution was needed to sustain this device for production. They came to Syncroness for our expertise in Sustaining Engineering with hopes of saving the device and creating some organization of its DHF. Learn how the client was able to maintain the production of its blood separation device and decrease its risk of production downtimes in this case study.

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