The master's thesis describes the process of automatic soldering, which is part of the manufacturing process for a medical device that must comply with the requirements of the ISO 13485 standard for medical devices. One of the standard’s requirements mandates that the manufacturer of medical devices conduct detailed medical validation and maintain records of it. Due to changes in the automatic soldering process revalidation was necessary. For this purpose, Design of Experiments (DOE) method was used to determine the optimal parameter values of influencing factors, including temperature, preheating time, wire feeding time and speed, and wire melting time. Using the proposed optimal parameters, 10 confirmation tests were conducted, and a confidence interval was determined, followed by cross-section analysis and validation according to the medical standard with 300 repetitions.
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