The new IVD regulation (IVDR) entered into force almost one and a half years ago. As the date of application for the IVDR is May 26th 2022, this means...

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With the release of the Medical Device Regulation (MDR) 2017/745 the Medicinal Product Directive in the EU has been revised and significant changes...

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Why care about labeling? Because this function connects the dots!

The label of your product includes all the essential information for a safe use of...

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U.S. Food and Drug Administration (FDA) and international regulatory standards continue to evolve and become more stringent. Medical devices are also...

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FDA is announcing their new five-part video series, designed to provide an overview of biosimilar and interchangeable products and to highlight key...

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Where are we now?

The Medical Device Regulation entered into force on May 26th 2017. Since then, the MDR was in focus on almost all relevant medical...

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The new IVD regulation entered into force on May 26th 2017 - exactly one year ago. As the date of application for the IVDR is May 26th 2022, this...

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Dirk Kreder has given an interesting insight in lifecycle management of combination products due to his workshop on June 19th (8:00 am) in Boston. ...

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anteris medical and Bellingswood periodically organize network meetings and workshops on various topics related to the regulatory requirements of...

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