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MHRA's recently published guidance on human factors

The guidance is intended for manufacturers, developers and notified bodies to highlight the important influence human factors have on patient safety. The advice is also relevant to device components of drug-device combination products that are regulated as medicines.

‘Human factors’ refers to how a person will interact with the system surrounding them, including the technology they use. Human factors takes into account the environment, user population and potential competing distractions.

Although it seeks to clarify regulatory expectations of medical devices marketed in the UK, the guidance does not represent a compliance requirement.

Please read the full post here.