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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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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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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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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