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Process Validation for Medical Device Manufacturers



Medical Device

What is Process validation? According to Wikipedia, it is the analysis of data gathered
throughout the design and manufacturing of a product to confirm that the process can reliably
output products of a determined standard.
As anyone who has gone through a validation process would tell you, the accuracy and
repeatability of the equipment used in the manufacturing process of medical devices are
critical to success.
Gathering weld data and then understanding that data to determine what steps need to be
taken is a primary concern in optimizing a weld—maintaining those optimized results in
production has, until now, been a guessing game. Manufacturers can stop guessing and
adequately determine the next step and then feel assured that the process they developed will
be reliable for the product’s life. How is that possible? By the introduction of Dukane’s servo
ultrasonic welding equipment with Melt-Match®.

When it comes to ultrasonic equipment choices, the evidence is clear (or should be): move
forward with proven servo-drive technological advances or stay with older pneumatically driven
technology and hope for the best. Although Dukane has been at the forefront of using
servo-drive technology in their ultrasonic welders since 2009, a few medical device
manufacturers are still reluctant to take the step forward. That’s like going into surgery with
equipment used in the 1970s versus what would be used today. I’ll take today’s technology;
thank you very much!
Dialing in and optimizing an ultrasonic welding process does not have to be a guessing game.
Take complete control of each phase in the ultrasonic welding process using Dukane’s Infinity™
Ultrasonic Welding System with Melt-Match®
. It delivers accuracy, reliability, and easy
replication of proven processes for faster and more cost-effective production.
Please contact us immediately for more information on how Dukane’s market-leading
technology can help you improve your quality, production yields, and ROI. Our experienced
applications and tooling engineers are ready to help make your program a success!