Clinical trials are a decisive method to evaluate the safety and efficacy of a device before they hit the market. "Substantial data" to me is more tha...

Balancing product innovation and patient safety is only possible with rigorous quality standards and a strict adherence to them. First, performing com...

All of the questions above are excellent and I would like to add a few other important ones. "How frequently does the problem occur?" and "Are there a...

In a medical device project, a robust monitoring and controlling process is crucial in clinical trials. These trials essentially determine the safety ...

Managing internal and external expectations can get really complex. In addition to having clear communication with everyone, critical decisions need t...