General
EMA moves into the direction of FDA. First guidance on new rules for certain medical devices
The time in which the European Medicines Agency did not care about medical devices is over. EMA has published the first of a series of
Clinical Research Insights
The time in which the European Medicines Agency did not care about medical devices is over. EMA has published the first of a series of
Since 06 December 2018 the guideline on the content, management and archiving of the TMF is final and will be effective from 06 May 2019
The bad news is “time flies”, the good news is “you are the pilot”. Regulation (EU) 2017/745 (MDR) will apply after a transitional period. Namely,
Why do so many companies run their clinical studies like driving with the car through the fog? In no other industry can you find so