EMA position on new regulatory requirements for Medicinal Products with device constituent part

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The anteris family of companies has grown!

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Qualification of Equipment as Part of Process Validation for Medical Devices

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We are rapidly approaching the end of the year. Time to review another eventful year in the history of anteris medical and its sister companies:

We…

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

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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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