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New guidelines: Summary of Safety and Clinical Performance (SSCP)

New guidelines: Summary of Safety and Clinical Performance (SSCP)

Summary of Safety and Clinical Performance: your device explained to your patients.

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Jun 2, 2022
When to update the CER? What does the regulation/guideline say, in an easy to understand way.

When to update the CER? What does the regulation/guideline say, in an easy to understand way.

Clinical Evaluation Report (CER) updates according to the MDR (EU) 2017/745

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Mar 28, 2022
EU IVDR: It’s about to begin!

EU IVDR: It’s about to begin!

EU IVDR 2017/746 will enter into force on the 26th of May 2022: here is all the important juice...

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Mar 28, 2022
Oligonucleotide Chemistry, Manufacturing & Controls: new tips from the German Federal Institute for Drugs and Medical Devices

Oligonucleotide Chemistry, Manufacturing & Controls: new tips from the German Federal Institute for Drugs and Medical Devices

The German Federal Institute for Drugs and Medical Devices, has given a workshop about the Oligonucleotide CMC Strategies for Quality Control. For oligonucleotides, starting materials are very important for the overall control strategy...

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Mar 28, 2022
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