Hand-held laser are much used in the production of medical device
products due to their flexibility in use. The process validation as
required by the FDA authorities makes specific demands to manual and
semi-automated welding processes.
Documentation of all relevant welding parameters
For this reason ROFIN integrates significant functions to support the
process validation into the welding systems Select and Integral. The
monitoring of all parameters crucial for welding processes, including
gas monitoring, guarantees a reliable and validated process. Combining
manual and CNC-controlled welding processes safeguards a highly
flexible and yet process-stable production.
Support of installation and operational qualification
In addition, ROFIN arranges for the realization and documentation of
the installation and operational qualification (IQ, OQ) for the Select
and Integral, according to the GMP standards for the FDA authorization
of medical device products.
More information at www.rofin.de/