Recently it was concluded jointly by industry and European Notified Bodies that there is less clarity in the use of EN 62304 than is desirable. As a consequence, it was decided to start a project to develop a paper with
MD&DI Interview Leo Eisner re:NB-MED Draft Doc EN60601 Implementation for EU
On Oct 6, 2011 MD&DI (Heather Thompson) interviewed Leo Eisner of Eisner Safety Consultants in regard to his blog posting on the NB-MED draft document “FAQ related to implementation of EN 60601-1:2006 Clarification of open issues”.