Unsure about medical device labelling?
Accurate labelling of medical devices is vital for the safe and proper use of medical devices by patients and care givers and is a key thing to get right when bringing a product to market. ISO 13485 considers medical device labelling includes the label, instructions for use, and any other information that is related to […]
Digital clinical safety risks and AI
The advent of artificial intelligence (AI) in healthcare promises to revolutionise patient care pathways, offering unprecedented advances in digital clinical support and decision-making systems. AI-driven systems have the potential to significantly improve condition severity assessments, treatment pathways, and diagnosis accuracy. However, their integration into healthcare settings introduces a new class of clinical risks that necessitate […]
