Risk Management in ISO 13485
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue [...]
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue [...]
Alignment with the Food Safety Modernization Act (FSMA) is necessary for manufac [...]
Regulators and standards organizations are increasingly requiring manufacturers [...]
Part 2 of a three-part EQMS blog series If you’re responsible for establishing [...]
There’s no question that quality risk management is becoming an indispensable to [...]
We live in a world where speed is vital to success. Patients and consumers expec [...]
Have you ever been part of a process that had a failure or two? Perhaps you’ve b [...]
ISO 13485 has undergone its first major overhaul of manufacturing system require [...]
A new FDA guidance concerning risk management helps medical device manufacturers [...]
Risk management remains a strong focus of the FDA. A revised FDA guidance offers [...]