Over the past two decades, the Army’s Role 3 hospital centers have achieved a 98% survivability rate—the highest in the history of modern warfare. The U.S. military’s ability to deliver unmatched ...

Anyone who has used a mechanical or technological device knows that devices tend to break down over time, and in few industries is this more manifest -- and more important -- than in healthcare.

The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control ...

Medical device lifetime expectancy is currently a hot topic in the industry, given the European medical device regulations requirement, EU MDR 2017/745, Article 18 1(c). Article 83 Post Market ...

Prior to the Medical Device Amendments (MDA) of 1976, medical devices generally had not undergone premarket review by the US Food and Drug Administration (FDA). The MDA created three classes of device ...