Rofin has revealed that its laser welding systems now have integrated functions that allow users to validation welding processes in such a way as to meet the exacting standards for medical devices.
Hand-held lasers are often used in the production of medical devices due to their flexibility in use, but process validation, as required by the FDA and other authorities, makes specific accountability demands on manual and semi-automated welding processes.
For this reason Rofin has integrated functions to support process validation into its Select and Integral welding systems. All parameters that are crucial for the welding process, including the yielding gas monitoring, can be monitored in order to guarantee a reliable process. The specific combination of manual and CNC-controlled welding processes result in a highly flexible and yet process-stable production.
In addition, Rofin supplies documentation of installation and operational qualification for its Select and Integral laser welders, which meet the GMP standards for the FDA authorisation of medical device products.