Risk Management is the process of identifying, assessing, and prioritizing risks followed by the application of resources to minimize, monitor, and control the probability and/or impact of adverse ...

Control charts have two general uses in an improvement project. Undeniably, the most common application is as a tool to ...

These definitions as written out by AAMI (The Association for the Advancement of Medical Instrumentation) offer clarity, helping designers recognize and address these risks effectively in product ...

Join our daily and weekly newsletters for the latest updates and exclusive content on industry-leading AI coverage. Learn More Today’s organizations rely on metrics more than ever before. Yet when it ...

Successful risk management is essential to the design and development of safe and effective medical devices. Unfortunately, it is too often viewed by manufacturers as an isolated activity that must be ...

IEC 60601 is no longer a standard of absolutes. The third edition allows, and in some instances requires, safety features and test requirements to be modified on the basis of risk management. By ...