Kennisbank: Clinical research with medical devices

What has changed in the new ISO14155:2020 standard?

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

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Harmonization EC approval process

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

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Introduction of Rianne Tooten

Rianne Tooten Rianne Tooten offers training, consultancy and guidance in the interpretation and practical implementation of the ISO14155 standard (the good clinical practice for clinical research with medical devices), the MDR (Medical Device Regulation) and regulatory strategies within The Netherlands. How? Through short video’s Rianne shares with you her knowledge and answers to the frequently

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Registration in publicly accessible databases

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 registration of

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Investigator Selection

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

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Risk Based Monitoring

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

Lees verder

Kennisbank: Clinical research with medical devices

What has changed in the new ISO14155:2020 standard?

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

Lees verder

Harmonization EC approval process

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

Lees verder

Introduction of Rianne Tooten

Rianne Tooten Rianne Tooten offers training, consultancy and guidance in the interpretation and practical implementation of the ISO14155 standard (the good clinical practice for clinical research with medical devices), the MDR (Medical Device Regulation) and regulatory strategies within The Netherlands. How? Through short video’s Rianne shares with you her knowledge and answers to the frequently

Lees verder

Registration in publicly accessible databases

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 registration of

Lees verder

Investigator Selection

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

Lees verder

Risk Based Monitoring

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

Lees verder
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