News

(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…

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

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

Happy Birthday MDR and IVDR - you are one year old now!

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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…

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. …

We invite you to take a look on our company profiles on LinkedIn and XING. You can find recent updates as well as interesting industry insights on…