What causes misses in self tests of 50% or even more? What do we know based on data from clinical practice? In part 1, I showed that the tests can have a miss rate of 1 out of 3 to 1 out of 4 when professionals use it, and even a miss rate of 1 […]
Lees meerThe miss rates of corona 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? In part 1, I showed that the tests can have a miss rate of 1 out of 3 to 1 out […]
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 […]
Lees meerWith the updated references of harmonised standards for medical devices, ISO 14155: 2020 is THE GCP standard for medical device clinical investigations, and since as of May 26th 2021 the MDR fully applies you may want to familiarize yourself and your team with the changes to ensure proper clinical data collection in line with this […]
Lees meerTo date numerous guidances, blogposts, webinars have been published addressing what one must and cannot do in the process of clinical evidence collection due to the COVID-19 pandemic (for overviews see here and here), and with this post I have no intention repeating that, but rather want to focus on the things we CAN do […]
Lees meerHow do you keep your legacy medical devices CE marked once the Medical Device Regulation (MDR) applies in May 2021? Can you continue to do what you did under MDD and are you then OK? A month ago, the Medical Device Coordination Group (MDCG) released a guide with the “how to’s” in MDCG 2020-6, a […]
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