Using any medical device brings with it an element of risk at the clinical level, where risk represents the probability of occurrence o...

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News from ISO : When the COVID-19 pandemic took hold, so too did the demand for ventilators. With patient safety at its heart, ISO’s commi...

The new ISO 13485 revision is here and, for medical device manufacturers, this is significant news. ISO 13485:2016 provides an int...

ISO 13485 sets out the requirements for a quality management system specific to the medical devices industry. It has recently been rev...

In an effort to cut down on the risk of superbug infections tied to a medical device used in hospitals, Olympus America has issued new pro...