QUOTED. Jan. 14, 2019. Jos Van Vroonhoven.
Jos Van Vroonhoven, a senior manager for standardization for Philips Healthcare and the convener of a joint working group that is revising risk management standard ISO 14971, said the document was upgraded to strengthen benefit-risk language and make its recommendations more clear. See what he had to say here.
"When revising the standard, we wanted to keep as much of it as possible the same. So, there are no changes to the risk management process, but there is more clarification and alignment with regulatory requirements that have changed. One of those changes by regulators is more emphasis on benefit-risk." –Jos Van Vroonhoven, senior manager for standardization, Philips Healthcare