Articles tagged with: Design

The use of equivalent spare parts not produced by the original device manufacturer is acceptable. Rules for manufacturers.

Insights into the regulation of medical devices with integrated AI-based functions.

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.