Ultrasonic welders are used to assemble a variety of plastic products. However, the requirements for a welder to make medical devices are much stricter than those for a machine to weld, say, toys or consumer products. Here’s a list of things to think about:
The most critical criterion for an ultrasonic welding system used in medical device manufacturing is the ability to support the secure capture of assembly data, when such data is used to comply with global regulatory requirements, including those of the U.S. Food and Drug Administration (FDA) and the European Union’s Medical Device Regulation. For example, FDA’s 21 Code of Federal Regulations (CFR) Part 11 for medical devices requires weld systems to validate users for system security, securely store weld data for individual products, create non-editable audit trails, and deliver data that meets traceability standards (unique device identifier or UDI).