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...
Devices already legally on the market under the European Union’s (EU) Medical Devices Directive (MDD) or the...
The ability to visualize a minimally invasive medical device or product during use is an important consideration...