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 this video I’m going to briefly answer the following question: “Is the ISO14155 applicable to the post-market stage of your clinical trial?” Transcript: In today’s video I’m going to briefly answer the following question: “Is the ISO14155 applicable to the post-market stage of your clinical trial?” In the latest 2020 version,
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 this video I’m going to briefly answer the following question: “Is the ISO14155 applicable to the post-market stage of your clinical trial?” Transcript: In today’s video I’m going to briefly answer the following question: “Is the ISO14155 applicable to the post-market stage of your clinical trial?” In the latest 2020 version,
