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There are three popular methods to hold a medical device or treatment onto the human body: tie it on, stick it on or suction it on. The first method was developed by our prehistoric grandparents [...]

If your medical device is reusable, a method for cleaning and disinfection must be specified by the medical device manufacturer as well as instruction for users on how to clean it. These elements [...]

The last thing a medical device manufacturer wants to receive in response to their FDA filing is a “request for additional information.” It’s usually not a deal killer, but at the very least it’s [...]

Within medical device companies, a dedicated team — either quality assurance (QA) or verification and validation (V&V) groups — is often tasked with ensuring that products in development meet a [...]

The way a surgeon handles a technologically advanced instrument in the operating room. The way a respiratory therapist interacts with the display on a mobile ventilator. The way a patient uses a [...]