Articles tagged with: Software

The responsibilities of platforms (such as App Store and Google Play) and MDSW manufacturers for the online distribution of medical apps.

Guidelines for proper qualification and classification of telemedicine software according to MDR and MDCG 2019-11.

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

Guidelines for UDI affixing process verification and validation obligations and our complete and compliant printing system.

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

The European Commission proposes postponing the medical device regulation. The content of the proposal and the new dates.

A classification rule applicable to all medical device software stipulates that these fall at least into class IIa.