Conformity Assessment Application

August 21, 2012

Plunkett Consulting has successfully assisted an Australian manufacturer lodge their first Conformity Assessment Application for Class IV in vitro diagnostics (IVD). This submission signifies a successful collaboration for the development of a Device Design dossier to demonstrate conformance with the Therapeutic Goods Administration (TGA) Essential Principles of Safety and Performance.

Contact us to discover how Plunkett Consulting can assist with navigating through the Australian regulatory system.