IMDRF issues guidance on predetermined change control plans (PCCPs) for software; #FDA and TGA align with similar frameworks. Non-software #PCCP guidance remains limited globally. Version control and post-market evidence are key focus areas. #Medtech #RegulatoryUpdates medmarc.com/life-science...

I'm excited to share our latest publication in #PCCP on anion dynamics in the deuterated ionic liquid [C₅Py][NTf₂], combining ¹⁹F fast field cycling(FFC) NMR relaxometry, NMR relaxation theory, and molecular dynamics (MD) simulation.

Assuring Transparency of AI Software after Deployment https://doi.org/10.1148/ryai.260811 #FDA #PCCP #MachineLearning

IMDRF has issued PCCP guidance for medical device software. #FDA and TGA continue aligning on intended use and version control, while non-software #PCCP guidance remains limited globally. Life sciences compliance continues to shift with the regulatory landscape. medmarc.com/life-science...