Kennisbank: Clinical research with medical devices

Key changes to regulatory application under MDR in the Netherlands

In this video the major changes to the regulatory submission in the Netherlands of clinical investigations is given.   Transcript:    These 6 key changes to the regulatory application in the Netherlands under the MDR are: The CCMO will be the competent authority for clinical investigations. A separate notification to the Health and Youth care Inspectorate

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Impact of MDR on clinical investigations

In this video the major changes of the MDR compared to the current laws for clinical investigations with medical devices with respect to the review and conduct of clinical investigations is highlighted.   Transcript:   In this video, I would like to highlight the major changes of the MDR compared to the current laws for

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Key changes MDR

In this video the most important aspects of the new European Union Medical Device Regulation, the MDR, are given.   Transcript:   In this video, I would like to highlight the most important aspects of the new European Union Medical Device Regulation, the MDR. The key changes include: Product scope expansion Implementation of the unique

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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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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

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Clinical evaluation vs clinical investigation

Clinical Evaluation vs. Clinical Investigation

You know by now what a medical device is; you’ve seen them, you’ve read about them, they stand to be one of the greatest medical inventions of our time. But, how does it come to life? Which processes are involved when placing a medical device on the market? A medical device follows a detailed set

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Kennisbank: Clinical research with medical devices

Key changes to regulatory application under MDR in the Netherlands

In this video the major changes to the regulatory submission in the Netherlands of clinical investigations is given.   Transcript:    These 6 key changes to the regulatory application in the Netherlands under the MDR are: The CCMO will be the competent authority for clinical investigations. A separate notification to the Health and Youth care Inspectorate

Lees verder

Impact of MDR on clinical investigations

In this video the major changes of the MDR compared to the current laws for clinical investigations with medical devices with respect to the review and conduct of clinical investigations is highlighted.   Transcript:   In this video, I would like to highlight the major changes of the MDR compared to the current laws for

Lees verder

Key changes MDR

In this video the most important aspects of the new European Union Medical Device Regulation, the MDR, are given.   Transcript:   In this video, I would like to highlight the most important aspects of the new European Union Medical Device Regulation, the MDR. The key changes include: Product scope expansion Implementation of the unique

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
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

Lees verder
Clinical evaluation vs clinical investigation

Clinical Evaluation vs. Clinical Investigation

You know by now what a medical device is; you’ve seen them, you’ve read about them, they stand to be one of the greatest medical inventions of our time. But, how does it come to life? Which processes are involved when placing a medical device on the market? A medical device follows a detailed set

Lees verder
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