Tag Archives: Postmarket Studies

A NEW VERSION OF ISO 14155: WHAT TO EXPECT?

The MDR as well as the current version of MEDDEV 2.7/1 reference ISO 14155 as GCP standard for medical device clinical investigations. Indeed, the 2011 version, but the third edition is in the making, so it can be good to … Continue reading

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NEED FOR CLINICAL EFFECTIVENESS DATA – OPPORTUNITY FOR MEDICAL DEVICES?

The report of the ENVI workshop on the Effectiveness of Medicines and Therapies is an interesting read from medical devices perspective: Typically the regulatory developments in medicinal products precede and therefore can predict upcoming trends for medical devices, and the … Continue reading

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