Kennisbank: Clinical research with medical devices

Safety reporting under MDR in The Netherlands part III

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

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Safety reporting under MDR in The Netherlands part II

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

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Safety reporting under MDR in The Netherlands part I

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

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Differences and improvements MDR and directives

In this video the top 3 general differences and improvements between the MDR and the previous Directives related to clinical investigations are given. Looking for In-Depth ISO14155:2020 training? Have a look at the e-learning at the academy.   Transcript:   In today’s video I’m going to answers the following question:   “What are the general

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Applicability of ISO14155 to Post Market Clinical Trials

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,

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Clinical requirements under the MDR

This week FAQ video is about the clinical requirements under the MDR. Would you like to know more about the differences between clinical evaluation and clinical investigation? Have a look at the article I wrote about this.   Transcript:   Good morning everyone, From my camper at my holiday, I would like to give you

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Kennisbank: Clinical research with medical devices

Safety reporting under MDR in The Netherlands part III

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

Lees verder

Safety reporting under MDR in The Netherlands part II

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

Lees verder

Safety reporting under MDR in The Netherlands part I

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

Lees verder

Differences and improvements MDR and directives

In this video the top 3 general differences and improvements between the MDR and the previous Directives related to clinical investigations are given. Looking for In-Depth ISO14155:2020 training? Have a look at the e-learning at the academy.   Transcript:   In today’s video I’m going to answers the following question:   “What are the general

Lees verder

Applicability of ISO14155 to Post Market Clinical Trials

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,

Lees verder

Clinical requirements under the MDR

This week FAQ video is about the clinical requirements under the MDR. Would you like to know more about the differences between clinical evaluation and clinical investigation? Have a look at the article I wrote about this.   Transcript:   Good morning everyone, From my camper at my holiday, I would like to give you

Lees verder
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