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…
IVDR Transition Project - A Brief Guide
Read out our full article here.
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…
Major Regulatory Change for combination Products in the EU - Are you prepared?
With the release of the Medical Device Regulation (MDR) 2017/745 the Medicinal Product Directive in the EU has been revised and significant changes…
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…
The importance of labeling and why talking to each other matters
Klick here to read our full article!
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
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