EMA INTRODUCES REGULAR SCIENTIFIC ADVICEPROCESS FOR HIGH-RISK MEDICAL DEVICES On January 17, 2025, the European Medicines Agency (EMA)published a guide […]
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The FDA has released a draft of new recommendations aimed at improving the performance accuracy of pulse oximeters, particularly across
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On 16 October 2024, the Medical Device Coordination Group (MDCG) published the revised guidance titled “Application of MDR Requirements to
MedTech Regulatory Insights January 2025 Read More »
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