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 [...]
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 [...]
Since the Covid pandemic, regulators and notified bodies have been doing more re [...]