The steps of a complex process can be displayed in sequence using a graphic referred to as a process flowchart. The graphic explains the way a process is or should be functioning, depending on the ...

If you’re in the medical device industry, you may think that design controls are a confusing imposition on your process. They’re a necessary part of your requirements as a medical device developer and ...

Medical device companies have long struggled with understanding design controls and making sure they are implemented correctly to ensure regulatory compliance. Jon Speer Design controls have been a ...

In January 1990, FDA published Device Recalls: A Study of Quality Problems (55 FR 21108, May 22, 1990). The study reported that 44% of quality problems were attributed to errors or deficiencies that ...