Understanding FDA Alignment of ISO 13485 with Quality System Regulation
The FDA’s official proposal to align its Quality System Regulation (QSR) with IS [...]
The FDA’s official proposal to align its Quality System Regulation (QSR) with IS [...]
This article is part one of a two-part series focused on GMP quality audit mana [...]
Technology, Politics, Climate, and the Coronavirus will Drive Maturation of Int [...]
Regulators and standards organizations are increasingly requiring manufacturers [...]