This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s ...

Innovation identifies a better way to meet an unmet need; the quality system makes that improvement reproducible, traceable, ...

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...

In the medical device industry, usability plays a critical role in ensuring the safety and effectiveness of highly complex medical products. The IEC 62366-1:2015 standard, which focuses on the ...