Articles tagged with: Standards

The hierarchy and comprehensive overview of MDR regulatory sources: regulations, EU acts, MDCG, CS, harmonized standards, and the state of the art.

Analysis of the new EN ISO 10993-1:2025 on biological safety, alignment with ISO 14971, and impact on documentation and testing.

EN 60601-1-2/A1:2021 impacts type tests, and its implementation may require repeating or performing certain tests.

There are very few standards harmonized with the MDR. A guide to choosing the most coherent ones and future harmonization timelines.

A series of concepts to approach the problem of searching for and choosing standards to apply with greater confidence.

The difference between DHF (Design History File), DMR (Device Master Record), and DHR (Device History Record) and the documents that compose them.

The logical flow of EN 14971, to address medical device risk management correctly and knowledgeably. In 4 points.