Date : 11-04-18 13:54
Requirement of software in MDD
 Name : CE Manager
Hit : 425  
ANNEX I
ESSENTIAL REQUIREMENTS

12. Requirements for medical devices
connected to or equipped with an energy source

12.1a For devices which incorporate software
or which are medical software in themselves, the
software must be validated according to the state of the art taking into account the principles of
development lifecycle, risk management, validation
and verification.