https://www.iso.org/standard/83968.html A new version of ISO14155 is currently under development, and on 20-JUN-2024 ISO/DIS 14155, replacing ISO14155:2020 when ready, entered the voting phase that terminates on 12-SEP-2024. A couple of interesting elements are in (potentially) impacting riskmanagement and safety for medical device clinical investigations (note the scope seems to have widened no longer excluding IVDs), […]
Lees meerThe miss rates of corona antigen self-tests as reported in practice are quite shocking compared those reported in the self-test labelling. What causes those misses? What do we know based on data from clinical practice? I looked at 6 reasons (and a bonus reason) that may explain why self-tests miss a diagnosis, and checked the […]
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