Knowledge Center: 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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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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ISO14155:2020 as a harmonized standard

What is the harmonized standard?  Last month, we discussed clinical evaluation and clinical investigation, during which we also touched on the ISO14155:2020. This month, we’re going to dive into this even further. The ISO14155:2020 is recognized as an harmonized standard. In accordance with Article 5(1) of the Council Directive, all EU member states should aim to follow certain

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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

Read More

Knowledge Center: 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

Read More

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

Read More

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

Read More

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,

Read More
ipad met logo rianne

ISO14155:2020 as a harmonized standard

What is the harmonized standard?  Last month, we discussed clinical evaluation and clinical investigation, during which we also touched on the ISO14155:2020. This month, we’re going to dive into this even further. The ISO14155:2020 is recognized as an harmonized standard. In accordance with Article 5(1) of the Council Directive, all EU member states should aim to follow certain

Read More

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

Read More
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