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 [...]
MORGAN HILL, CA, UNITED STATES, March 31, 2022 – AssurX, Inc. (AssurX), a leader [...]
As we move through 2022, we look forward to new opportunities, new challenges, a [...]
This article is part two of a two-part series focused on GMP quality audit manag [...]
This article is part one of a two-part series focused on GMP quality audit manag [...]
Since the Covid pandemic, regulators and notified bodies have been doing more re [...]
Technology, Politics, Climate, and the Coronavirus will Drive Maturation of Inte [...]
Regulators and standards organizations are increasingly requiring manufacturers [...]
Part 3 of a three-part quality automation blog series We live in a time of rapid [...]
Part 2 of a three-part EQMS blog series If you’re responsible for establishing o [...]