Blog

TGA acceptance of international device reviews – clearing the fog

Arthur Brandwood ,  20 December, 2019

Brexit appears inevitable – and it seems UK MHRA will emulate New Zealand!

Arthur Brandwood ,  19 December, 2019

A single review program for medical devices?

Luis Jimenez ,  2 December, 2019

The door to Europe is closed – so where else should I look?

Arthur Brandwood ,  2 December, 2019

Are Harmonised Standards facing irrelevance?

Arthur Brandwood ,  4 November, 2019

The question on clients’ lips… “How long will my application take?”

Orsola Regaglia ,  4 November, 2019

TGA Publishes updated MDIR Guide

Grant Bennett ,  31 October, 2019

EU Software Classification under MDR/IVDR – New Guidance Document

Yervant Chijian ,  28 October, 2019

Out They Go – FDA Clears the Store of Guidances

Arthur Brandwood ,  25 October, 2019

FDA Fashion Parade – Guidance Priorities for Fiscal 2020

Arthur Brandwood ,  25 October, 2019