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MDD93/42/EEC or EN13485?

Writer's picture: Redstar MedicalRedstar Medical

The EU standard governing the rules of design and manufacture of Medical Devices have changed through the years. They have progressed to extending the directive to cover the routine maintenance of devices in order to ensure the correct manufacturers operational performance! Most manufacturers recommend annual servicing of their equipment, and additional calibration requirements where measurement/recording sensors are fitted.

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