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December 11, 2018

Qserve Team Update

Qserve is pleased to welcome 3 new colleagues!
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December 10, 2018

ISO 14155 - Good Clinical Practice in the spotlights!

By reading the MDR the trend seems to be that there is increasing attention for clinical, by referring to sufficient clinical evidence of sufficient quality. Personally, I cannot be happier! Clinical is my favorite topic of interest, but let’s be honest, clinical decision making can be complex and activities are costly. Therefore,..
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December 10, 2018

What will be the impact of the EU MDR on clinical data collection in Investigator Initiated Studies?

An Investigator Initiated Trial or Study IIT/ IIS is a research effort in which the investigator designs and implements the clinical study and the investigator acts as the study sponsor. As the sponsor, the Investigator assumes all responsibilities for complying with applicable regulatory requirements. 
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December 10, 2018

Key Opinion leader engagement for your clinical investigation

Key opinion leaders (KOLs) are experts and thought leaders in their field. They are an important resource for R&D, market access and clinical investigations. KOLs can add great value to your clinical investigation by helping you develop a credible study protocol with scientifically relevant outcomes.
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December 10, 2018

Where do Clinical Evaluation and Clinical Investigation meet?

A clinical investigation is often the keystone of evidence to prove that your medical device is ready to enter the market. 
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