Knowledge Center: Clinical research with medical devices

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 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 asked questions

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Veranderingen op komst door Europese Medische Hulpmiddelen Verordening – Meer klinisch bewijs over veiligheid en prestatie

Op 26 mei 2020 treedt de Europese Medische Hulpmiddelen Verordening (EU) 2017/745 (MDR[1]) in werking. Vanaf die datum gelden striktere eisen voor medische hulpmiddelen om in aanmerking te komen voor markttoelating in de Europese Unie, in het bijzonder met betrekking tot klinisch bewijs van veiligheid en prestatie. Fabrikanten van medische hulpmiddelen zijn voor het verzamelen

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Knowledge Center: Clinical research with medical devices

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

Read More

Introduction of 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 asked questions

Read More

Veranderingen op komst door Europese Medische Hulpmiddelen Verordening – Meer klinisch bewijs over veiligheid en prestatie

Op 26 mei 2020 treedt de Europese Medische Hulpmiddelen Verordening (EU) 2017/745 (MDR[1]) in werking. Vanaf die datum gelden striktere eisen voor medische hulpmiddelen om in aanmerking te komen voor markttoelating in de Europese Unie, in het bijzonder met betrekking tot klinisch bewijs van veiligheid en prestatie. Fabrikanten van medische hulpmiddelen zijn voor het verzamelen

Read More
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