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. 2016 Dec 7;40(1):37–47. doi: 10.1007/s40264-016-0474-1
The collection of safety information and its integration into the risk management process for medical devices is not consistent.
Collaboration between all stakeholders is needed to develop a more proactive safety evaluation process.
This new process should incorporate real-world data to develop a risk assessment model that is suitable for all medical devices.