Successful quality system remediation relies on understanding why problems arose, generally referred to as “root cause analysis.” ...
We were recently invited by the orthopedic market intelligence firm ORTHOWORLD® to describe our experiences with clinical...
There is much interest in engaging patients in the medical device development process, at all stages of...
FDA Warning Letters are devastating – a Quality Manager’s worst nightmare – a major shock to any...
Although the implementation of EU MDR has been postponed for up to one year, it will be...
There are several safety concerns (risks) for patients who require a minimally invasive procedure. One of the...