Dirk Kreder is invited as a speaker at the Drug/Device Combination Product Summit in December in Berlin!

His presentation takes place on Tuesday, 04...

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IVDR Transition Project - A Brief Guide

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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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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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