I’m often asked by Software QA Managers why their testing team is unable to find all the critical defects in the software, before it’s released to production. “Why are high severity bugs escaping to...
When you look at the big picture, you see impacts such as: unfavorable customer perception cost of expensive 3rd level support demoralized engineering staff a severely overloaded tech support team And that makes sense, because...
There you are in the middle of a large-scale hospital systems project, where new medical devices need to integrate with several clinical & billing applications – and there seems to be no end to...
Recently I was explaining how we could help medical device companies prevent a recall, and my happy listener balked. She couldn’t accept what she heard. I told her that – essentially – by using...
Let’s start with Recalls… Essentially, when a company learns there is a problem with one of their medical devices, it proposes a correction or a removal depending on where the action takes place. Correction...
