The principal objective of a QMS for a medical device company is patient safety. Patient safety is well understood and communicated throughout the medical device industry, leading to an almost...
In the second blog post in this series, we explained that a lean QMS results in less complicated devices, which in turn decreases development time, cost, and, in many cases, patient risk. Less is...
In the 3rd part of this series, we address how to balance empowering a design team to create a medical device that provides safe and effective therapy or diagnostic, while still ensuring adequate...
