Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

On average, around 4,500 drugs and medical devices are pulled from shelves across the United States each year. 1 This alarming statistic underscores the importance of controlling and mitigating risk ...

Here's an all-too-common scenario that occurs when a medical device company acquires another firm. The acquisition candidate demonstrated an impressive working prototype. The preliminary clinical data ...