International – Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies...
This document defines the content of the Regulatory Assessment Program and
provides guidance on the process-based assessment method. The Assessment
Program defines how Regulatory Authorities will...
International – Final Document- Principles of Labelling for Medical Devices and IVD Medical Devices
The purpose of this IMDRF guidance is to provide globally harmonized labeling
principles for medical devices, including in vitro diagnostic (IVD) medical devices, and
support IMDRF/GRRP...
