According to Eurasian Economic Union (EAEU) requirements manufacturer must conduct safety monitoring of medical devices to ensure that medical device is safe and effective. Now it’s necessary to build a monitoring system for analytical and process reports and send them to the regulator in accordance with legislation. Besides, for II B, III classes of medical devices and implantable devices manufacturer must provide medical device efficiency and safety report within the first 3 years after registration.
X7 Research provides safety monitoring of medical devices and develop needed reports according to legislation
QUALIFIED REPRESENTATIVE FOR MEDICAL DEVICE VIGILANCE
MEDICAL DEVICE efficiency AND SAFETY REPORTS DEVELOPEMENT
X7 Research has been conducting pharmacovigilance activities in Russia, EAEU, CIS since 2010. Our experts have a lot of experience in this field and have compliance with all regulatory requirements. This is our main advantage.
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