Medtech Regulatory

MedTech Regulatory Insights May 2025

Medtech Regulatory, Medical Device, Medical Device Consultancy, Medtech Consulting, Medtech Consultant,

Regulatory Radar Australia Enforces UDI Regulations – New Era for Device Traceability Begins Australia’s Unique Device Identification (UDI) regulations are […]

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MedTech Regulatory Insights March 2025

EMA INTRODUCES REGULAR SCIENTIFIC ADVICE PROCESS FOR HIGH-RISK MEDICAL DEVICES On January 17, 2025, the European Medicines Agency (EMA) published

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MedTech Regulatory Insights Feb 2025

The FDA has released a draft of new recommendations aimed at improving the performance accuracy of pulse oximeters, particularly across

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MedTech Regulatory Insights January 2025

On 16 October 2024, the Medical Device Coordination Group (MDCG) published the revised guidance titled “Application of MDR Requirements to

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