BSI would have been disappointed if it had received the comments featured in the first expert panel opinion, but vice-president Gary Slack believes the report provides many insights and opportunities around how this scrutiny process will impact the sector.
Expert opinions should raise the bar in the EU for the clinical review of high-risk devices by notified bodies, in what Gary Slack, senior vice president of the notified body at BSI Regulatory Services (Medical Devices), calls a much-needed improvement.
This is because the level of clinical scrutiny of these products by notified bodies has been “variable” in the past, he said, adding that anything that creates a consistently high...
Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.
A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
