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 ...
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 ...
We are living in an unprecedented era of rapid medical innovation in the face of COVID-19. The speed of development for devices and diagnostics has been driven by the urgency of the pandemic resulting ...
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