Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices
Title:
Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices
Origin/Publisher:
GHTF
Document Type:
Guideline
Content:
This document has been developed to encourage and support global convergence of regulatory systems. It is intended for use by Regulatory Authorities, Conformity Assessment Bodies and industry, and will provide benefits in establishing, in a consistent way, an economic and effective approach to the control of IVD medical devices in the interest of public health.