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September 17, 2019

Monitoring in medical device studies: what is needed?

If you are a manufacturer who started a clinical trial, then you have the obligation to adequately monitor the study (MDR Article 72, par. 2; ISO 14155:2011). Monitoring is the act of overseeing the progress of a clinical investigation and to ensure that it is conducted, recorded, and reported in accordance with the CIP, written procedures, Good Clinical Practice, and the applicable regulatory requirements.
September 16, 2019

Interview with Gert Bos in Focus

European Commission President-elect Ursula von der Leyen unveiled her new team of commissioners-designate this week, including the addition of Stella Kyriakides, a medical psychologist from Cyprus, to lead the health portfolio.
September 12, 2019

No deal Brexit : UK responsible Person

No-deal Brexit news – registration of medical devices and IVD on the UK market. The situation in the UL can change rapidly however it is still possible that there will be a no-deal Brexit. The regulatory consequences for the medical industry are as follows. 
September 12, 2019

Giovanni Di Rienzo joins Qserve

Qserve Group is pleased to announce that Giovanni Di Rienzo joins Qserve to further expanding its capabilities to support the medical device industry worldwide. Giovanni is a leading expert for vascular devices, having years of experience in industry and Notified Bodies.
September 04, 2019

FAQ Top 5 IVDR: Get your company ready


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