The ISO14155 provides an important guide on the use of Good Clinical Practice in clinical investigations. In the ISO14155 you’ll find the main requirements to: protect the well-being, safety and rights of human subjects in the clinical investigation; assure the scientific relevance of the investigation and the trustworthiness of its results; define what the sponsor
In today’s video, I will briefly answer the following question: “How is the approval process of Ethics Committees harmonized under the MDR?” Transcript: Ethics committees are responsible for evaluating a clinical investigation and determine whether ethical principles are being met. Requirements related to ethics committee composition and function are not specified in the
The registration of clinical investigations and their results in public databases is one of the key requirements of the new version of the ISO14155, and a widespread requirement in international and federal regulations, such as the FDA and the MDR. In today’s video I will briefly answer the following question: “Why is the
In a former video, we talked about the importance of quality management in a clinical investigation. In today’s video I will briefly answer the following question: “Why is the selection of investigators so important for the success of your clinical investigation and market access of your medical device? As mentioned in the video
In a previous video we discussed the relationship between risk management and the ISO14155. Today we’ll answer the following question: “How is risk management integrated in the conduct of your clinical investigation?” Transcript: Whether it is related to monitoring or adverse events reporting, risk management activities should be performed continuously throughout the conduct
In today’s video I will briefly answer the following question: “Why and how should quality management principles be applied in your clinical investigation?” Transcript: The inclusion of guidance with regards to clinical quality management, is one of the main changes to the new version of the ISO14155. Why? To ensure that the clinical
The ISO14155 provides an important guide on the use of Good Clinical Practice in clinical investigations. In the ISO14155 you’ll find the main requirements to: protect the well-being, safety and rights of human subjects in the clinical investigation; assure the scientific relevance of the investigation and the trustworthiness of its results; define what the sponsor
In today’s video, I will briefly answer the following question: “How is the approval process of Ethics Committees harmonized under the MDR?” Transcript: Ethics committees are responsible for evaluating a clinical investigation and determine whether ethical principles are being met. Requirements related to ethics committee composition and function are not specified in the
The registration of clinical investigations and their results in public databases is one of the key requirements of the new version of the ISO14155, and a widespread requirement in international and federal regulations, such as the FDA and the MDR. In today’s video I will briefly answer the following question: “Why is the
In a former video, we talked about the importance of quality management in a clinical investigation. In today’s video I will briefly answer the following question: “Why is the selection of investigators so important for the success of your clinical investigation and market access of your medical device? As mentioned in the video
In a previous video we discussed the relationship between risk management and the ISO14155. Today we’ll answer the following question: “How is risk management integrated in the conduct of your clinical investigation?” Transcript: Whether it is related to monitoring or adverse events reporting, risk management activities should be performed continuously throughout the conduct
In today’s video I will briefly answer the following question: “Why and how should quality management principles be applied in your clinical investigation?” Transcript: The inclusion of guidance with regards to clinical quality management, is one of the main changes to the new version of the ISO14155. Why? To ensure that the clinical
