AI Health Apps. More Than Just Wellness Tools
AI’s potential to transform healthcare has resulted in AI applications built to assist with everything from patient monitoring to diagnostic support.
Intended Use under MDR
In Health Tech, establishing the intended purpose of a product is a critical first step that can influence the success of a project.
Is My Software a Medical Device?
This article focuses on stand alone software active in the European Market and subject to the Medical Device Regulation.
Software Medical Device Classification
The criteria for classifying software as medical devices and the regulatory challenges faced by MDSW manufacturers can sometimes be confusing
Post-Market Surveillance for Healthcare Software
Post-Market Surveillance, or PMS, is vital for ensuring that healthcare software remains safe and fit for purpose
Risk Management for Healthcare Software
Health Software Risk Management is all about making sure software does what it’s supposed to do and meets the needs of its users.