EU Notified Bodies – Page 2 – Eisner Safety Consultants

Do you know how to use EN62304 (med dvc s/w life-cycle) as implemented under the EU MDD & AIMDD?

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