This seminar provides a detailed introduction to the European Medical Device Legislation. It will explain the Directives and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do. It will also cover the documentation necessary to apply for the CE Mark.
.Understand the Medical Device Directives
.Learn the Role of a Notified Body
.Know what a Competent Authority Expects
.Hear More on Classification
.Understand Conformity Assessment Procedure
.Understand the Medical Device Directives
.Learn the Role of a Notified Body
.Know what a Competent Authority Expects
.Hear More on Classification
.Understand Conformity Assessment Procedure
