The proposed new EC ordinances on medical devices and in vitro diagnostic devices may not be adopted prior 2016. This is shown by a progress report of the General Secretariat of the Council of the European Union from 25 of November 2014. Many medical device manufacturers still do not know what to expect for their regulatory situation!
The PROSYSTEM informs its customers immediately about such planned changes. Furthermore, the impact of such changes on your medical devices, which are already on the market, will be identified and evaluated. Data will be collected through market research, observations, customer surveys, competitor monitoring and evaluation of complaints in order to avoid unnecessary retrospective activities.
Our consultants evaluate technical solutions through risk assessment and clinical evaluation and assist you in determining the possible corrections, corrective- or preventive-actions (C / CA / PA).