Nenne zwei Eingaben zur Überwachung nach dem Markteintritt im NDD?

Antwort

Post-Market Surveillance (PMS) in the context of devices, including those in non-diagnostic (ndd), typically involves various inputs. Two key inputs are: 1. **Adverse Event Reports**: These are reports of any negative outcomes or side effects experienced by patients or users after the device has been marketed. They provide critical data for assessing the safety and effectiveness of the device in real-world settings. 2. **User Feedback and Surveys**: Collecting feedback from healthcare professionals and patients regarding their experiences with the device can provide valuable insights into its performance, usability, and any issues that may arise during its use. These inputs help manufacturers and regulatory bodies monitor the ongoing safety and effectiveness of medical devices after they have been approved for market use.

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