Periodic Reporting for period 1 - LymphoDrain (First subcutaneous implant to treat lymphedema. Definitive solution for chronic lymphedema)
Reporting period: 2017-12-01 to 2018-03-31
The main objective of the project is to meet regulatory requirements and obtain CE-mark in order to start commercialization of LymphoDrain in the European market. To this end, clinical evidence must be obtained which will be achieved through pre-clinical tests and clinical validation and the Quality Management System implemented in accordance with the requirements of the International Standard EN ISO 13485:2016.