To maintain your compliance with the related regulations throughout the medical device life cycle, The new European medical device regulation (MDR) requires manufacturers to submit a Clinical Evaluation Report (CER). The MDR defines the ‘clinical evaluation’ as a systematic and planned process to continuously generate, collect, analyses and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer. We provide post-market compliance solutions, incident reporting, and global vigilance support informed by a life-cycle approach to device safety and effectiveness.
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