Use it or lose it: Why off-label data should not be ignored! Danielle Giroud and Erik Vollebregt discuss the challenges and opportunities of using off-label data to expand the intended purpose of a medical device under the MDR.
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Question: How do you go about turning safety claims into clinical endpoints on CE-mark studies?
MD-Clinicals’ Danielle Giroud and Renata Nogueira explore the aspects of quantifying safety claims in this insightful discussion bringing the specifics behind defining your safety claims under MDR.
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Remote monitoring, when applied under a risk management process in the planning of a clinical investigation, can be a useful tool in addition or in lieu of onsite-monitoring. Although early experience showed some resistance which gradually went away with forced remote activities during the pandemic, we see that with the necessary flexibility in applying tailormade solutions for the sites, remote monitoring becomes a quite appreciated monitoring solution. Ivon Septriyana provides some tips and tricks on applying remote monitoring in SE-Asia studies with medical devices.
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