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 [...]
When evaluating an automated QMS, the question to invest in configuration vs. ou [...]
EU Medical Device Regulation (MDR) has been in effect for almost a year. As anti [...]
In recent months, the U.S. Food and Drug Administration (FDA) has issued a dozen [...]
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 [...]
There’s no question that quality risk management is becoming an indispensable to [...]
Let's start with a scenario that illustrates the methodology behind using decisi [...]
In Stephen Covey’s 7 Habits of Highly Effective People, the author famously exho [...]
Imagine that you’re a manufacturer of skincare products detecting a spike in com [...]