[FEATURED] EU Proposal To Have Guidance Transition Periods “Does Not Make Sense”
A proposed position paper on time periods for notified bodies to roll out guidance documents aims to introduce greater predictability. But has the EU notified body organization gone too far […]
[FEATURED] FDA Publishes Final Guidance On Clinical Decision Support Software, Clarifies What Software Should Be Regulated As Medical Devices
In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision support software from being regulated as medical devices under federal law. Software […]
[FEATURED] EU’s Risk Management Standard Officially Recognized In Context of the IVDRU
Only one new standard has been added to the official list of standards recognized in the context of the EU IVD Regulation in the latest update. The good news is […]
