ldavis

Entries by Liam Davis
ISO13485:2016 TGA requirement

ISO 13485:2016 – The race is on…

With the Olympics still fresh in our minds, it seems fitting that the TGA announced their race times for the complete implementation of ISO 13485:2016 certification as opposed to ISO 13485:2003 acceptance.
On your marks…
In …

data measurements

MHRA: Data Integrity defined?

In July 2016, the MHRA released a draft document for consultation entitled MHRA GxP Data Integrity Definitions and Guidance for Industry.  As the name suggests, it is a glossary of DI terms where the …