Hi Ronen, thanks for the statement. What should I ask the toxicologist? We don`t have leachable substances to evaluate. In my opinion the ISO...
It`s the applied part of the medical device. No other part is in contact with the patient.
Hi Nikolaos, it depends from the function to be tested and the monitoring device to detect the failure mode (e.g. display change rate). If you...
The single use component is part of a medical device (accessory). We are the manufacturer of this medical device and the belonging single use...
Hello, we are planning a biological evaluation for a single use component. The component will apply to the mucousal membran for a short time...
Hi Nikolaos, what´s your problem? How can I help you? At the Moment I`m preparing a test plan for the 4th Edition. Achaos
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