Risk Management in ISO 13485
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue i [...]
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue i [...]
This article is part one of a two-part series focused on GMP quality audit manag [...]
Technology, Politics, Climate, and the Coronavirus will Drive Maturation of Inte [...]
Regulators and standards organizations are increasingly requiring manufacturers [...]
There’s no question that quality risk management is becoming an indispensable to [...]
Combination products (CPs) have revolutionized drug delivery and patient care, b [...]
Three recent warning letters from the Center for Device and Radiological Health [...]