QualityMedDev

FDA Digital Health Devices Regulation - Pre-Cert Program FDA has launched the so-called Software Pre-Cert Program. The goal is to provide a specific regulatory pathway for market access which is more

Very recently, ISO published a new version of ISO 14155:2020 - Clinical investigation of medical devices for human subjects — Good clinical practice. The new ISO 14155:2020 provides an

ISO 15223-1:2021 new symbols for medical devices In this paragraph, we will talk about the update of ISO 15223-1 that will introduce new symbols to add in the labelling of medical

Insights into the ISO 13485 certification process for Quality Management System. ISO 13485 certification is the process to certify that a quality management system is able to ensure quality,

ISO 13485 FDA ISO 13485 and FDA: Harmonization with FDA QSR and insights on next version of ISO 13485 In this paragraph we want to discuss about the future integration between ISO