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Table of Contents
Table of Contents.....................................................................................................................................................1
1.0 Purpose..........................................................................................................................................................2
2.0 Scope.............................................................................................................................................................2
5.0 Procedure......................................................................................................................................................2
1.0 Purpose
The purpose of this document is to outline the procedure for conducting human clinical studies.
2.0 Scope
This procedure applies to all human clinical studies conducted using products developed at the [City],
[State] facilities of [Company X].
5.0 Procedure
[Insert procedures for conducting a clinical human trial. Include as appropriate FDA Medical Device
Clinical Study Guidance and the European Standard EN 540 including the design and conduct of the
study protocol].