Anne Collard

3 articles

Regulatory AffairsFeb 20, 2025 6 min

Cómo orientarse en el laberinto de normas internacionales, europeas y armonizadas sobre productos sanitarios

Es importante entender cómo se escriben las normas y cómo se construyen sus referencias para poder referenciarlas correctamente y comprar la versión correcta para su uso. En esta entrada del blog, explicamos la diferencia entre las normas ISO e IEC, qué son las normas armonizadas y cómo utilizar ...

Quality AssuranceAug 13, 2024 3 min

Outsourcing Internal Audits: Benefits and Process Optimization in Your Pharma Company

Boost compliance, optimize resources, and gain unbiased insights by outsourcing internal audits in your pharma company.

Regulatory AffairsAug 8, 2022 5 min

Finding your way through the maze of international, European, and harmonized standards for medical devices

Learn the difference between ISO vs IEC standards, what (EU) harmonized standards for MDs are, and how to use the correct standard references.

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