An essential part of quality management according to the General Medicine Act (MPG) and the US FDA's Code of Federal Regulations (CFR), is the...

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We had many things to publish and spread over the world last year. At least an interesting White Paper series with different exciting topics.

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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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