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European Medical Device Nomenclature (EMDN): A Key to EU Compliance

European Medical Device Nomenclature (EMDN): A Key to EU Compliance

This comprehensive system is crucial for manufacturers who are navigating the complexities of EU regulations and EUDAMED

28.1.2025

The Human Touch in Regulatory and Quality Compliance: Why Consultants Still Matter in the AI Era

The Human Touch in Regulatory and Quality Compliance: Why Consultants Still Matter in the AI Era

Why not rely solely on AI for creating technical documents, implementing ISO standards, or managing regulatory and quality compliance?

23.1.2025

Mastering TPLC for Medical Softwares

Mastering TPLC for Medical Softwares

The Total Product Life Cycle (TPLC) encompasses all phases of a medical device's life, from initial concept through post-market surveillance.

14.1.2025