Braile Biomédica

The post-marketing surveillance of Braile Biomédica is carried out by means of research and revision of scientific literature of equivalent product, and by post-marketing clinical follow-up. It has documented methods and procedures that confirm clinical performance and safety over the life expectancy of the medical device. According to European Regulation 2017/745, the manufacturer must notify the competent authorities in the event of any adverse event related to the product / packaging. The "Implant / Performance Record" form must be completed immediately after the surgery and presented to Braile by the Commercial Technical Consultant, Distributor or Representative of the internal and external markets. All Post-Marketing Surveillance data is considered confidential, and will only be accessed by the departments involved in the surveillance process and by the Notifying Body. Patient identification and information are protected by the General Data Protection Law.