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General

A medical device is not a drug. This is an obvious statement but it is surprising how may people overlook the obvious. There are many differences between devices and drugs: product development, regulatory issues, product life, users and markets to name a few important ones. You know that your device is not a drug. You also know that some consultants only recognize what they know. That might explain why some medical device manufacturers let themselves be led by their advisors on the long and extensive (very often much more expensive) route of 'pharma-alike' trials. We leave the pharma clinical research to the other CRO's because we are the experts on clinical research for medical devices.

All our operations are according to our ISO 9001 qualified Standard operational Procedures based upon EN540 and ICH-GCP