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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Therefore we constantly keep up to date with hot topics in our industry.
The PDA membership gives us access to…
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…
(Nearly) everything you always wanted to know about... Design Verification
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…
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