Harmonization of Software Requirements through Standards

Rainer Voelksen, Vice-President for International Regulatory Affairs at Edwards Lifesciences, joins Pharma IQ to discuss why standards should have internationally compatible software requirements. He also touches upon the European QM approach, the GHTF project and the International Medical Device Regulator Forum in the interview. Rainer Voelksen will be among the speakers at the forthcoming conference: Software Design for Medical Devices Europe 2013, taking place 29 January - 01 February... To continue reading this story Click Here