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
We have spent a couple of videos looking at safety reporting, to better understand it’s role in the MDR, the Medical Device Regulation. Today, we’re going to tackle a broader question that also encompasses everything we’ve been talking about with safety reporting: How is risk management related to the ISO14155? Transcript:
Until now, we have discussed what safety reporting is and how it works. But today, we will answer another important question related to this topic: What does a serious health threat mean? Transcript: In other words, how do you know if something constitutes a serious health threat? The purpose of safety
In this video, the following question is briefly answered: “When does vigilance reporting apply and who is responsible for this process?” Transcript: In this “trilogy” we talk about the safety reporting of different legal frameworks in The Netherlands. The last 2 weeks we talked about safety reporting for clinical investigations that are
In this video, the following question is briefly answered: “How do clinical investigations under article 82 comply with safety reporting in The Netherlands?” Transcript: Last week, we began looking at safety reporting. Today, we’re going to briefly focus on the following follow-up question: How do clinical investigations under article 82 comply with
In this video, the following question is briefly answered: “Which clinical studies in The Netherlands must comply with the safety reporting under article 80 of the MDR?” Transcript: In today’s video, the following question is briefly answered: “Which clinical studies in The Netherlands must comply with the safety reporting under article 80 of the
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
We have spent a couple of videos looking at safety reporting, to better understand it’s role in the MDR, the Medical Device Regulation. Today, we’re going to tackle a broader question that also encompasses everything we’ve been talking about with safety reporting: How is risk management related to the ISO14155? Transcript:
Until now, we have discussed what safety reporting is and how it works. But today, we will answer another important question related to this topic: What does a serious health threat mean? Transcript: In other words, how do you know if something constitutes a serious health threat? The purpose of safety
In this video, the following question is briefly answered: “When does vigilance reporting apply and who is responsible for this process?” Transcript: In this “trilogy” we talk about the safety reporting of different legal frameworks in The Netherlands. The last 2 weeks we talked about safety reporting for clinical investigations that are
In this video, the following question is briefly answered: “How do clinical investigations under article 82 comply with safety reporting in The Netherlands?” Transcript: Last week, we began looking at safety reporting. Today, we’re going to briefly focus on the following follow-up question: How do clinical investigations under article 82 comply with
In this video, the following question is briefly answered: “Which clinical studies in The Netherlands must comply with the safety reporting under article 80 of the MDR?” Transcript: In today’s video, the following question is briefly answered: “Which clinical studies in The Netherlands must comply with the safety reporting under article 80 of the
