How to check your production documentation for audit readiness: Once production starts, it's too late for uncertainties in the documentation. A missing test report, an unclear work instruction, or an incomplete FMEA – and the audit or series release is already on the horizon. ...
01/22/2025
We are pleased to welcome Diana Madzar as the new Production Manager for Medical Devices at MEDtech Ingenieur. Since the beginning of 2025, she has taken over the management of our production department and will play a key role in the further development of our company. Diana has ...
03/15/2021
Anyone seeking approval for a medical device in the United States cannot avoid the Food and Drug Administration (FDA). Medical devices are becoming increasingly interconnected and are collecting more and more data. ...
Electrical fuses are essential components for the electrical safety of medical electrical equipment (ME equipment). They protect the device from incorrect operation, connection to excessively high or reversed supply voltages, and they protect the operator and patient in the event of electrical hazards. ...
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