Major Regulatory Change for combination Products in the EU - Are you prepared?

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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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We ain´t satisfied until you are!

Therefore we constantly keep up to date with hot topics in our industry.

The PDA membership gives us access to…

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The importance of labeling and why talking to each other matters

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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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(Nearly) everything you always wanted to know about... Design Verification

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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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While joining the the Combination Products Lifecycle Management Summit in Boston, Dirk Kreder gave some insights in "Lifecycle Management of…

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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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