Standards for Medical Device Products - ROFIN Supports Validation of Welding Processes for Approvals
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.
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