Reprocessing Validation: Proof of the Maximum Lifecycle of your Medical Device
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How long is a medical device safe to use? As a medical device manufacturer, you must answer this question reliably and comprehensibly for users and patients. According to standards and regulations such as MDR 2017/745 and DIN EN ISO 17664, you are obliged to prove the maximum lifetime of your reusable product and to provide corresponding information in the instructions for use. We support you in this process with our highly specialized services. With modern washer-disinfectors and steam sterilizers (autoclaves), we perform the stress test for your instruments. We reliably validate the service life of your medical device, simulating a maximum number of reprocessing cycles.
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