The medical device technical file is a must-have document for devices to be sold in the European Union (EU) marketplace. The file contains detailed information about your medical device, its design, intended use claims, composition, and clinical evaluations.

Root cause analysis (RCA) is the process of finding the basic underlying cause for an effect we observe or experience. In the context of failure analysis, RCA is used for finding the root cause of frequent machine malfunctions or a big machine breakdown.

Remember the last time you tried to change your habits in a big way? Perhaps you made a vow to eat healthier, or to listen more actively during meetings.

In March 2001, publishing executive Ann Godoff—then in her third year as president, publisher, and editor-in-chief of Random House Trade Publishing Group (RHTPG)—was the subject of a gushing prof

During the past year, the U.S. Food and Drug Administration’s (FDA) approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate.

In 2019, Nicholas W. Eyrich, Robert E. Quinn, and David P.

Iam often asked by customer service leaders how to get the CEO to care about customers. They are convinced there is a missed tactic that, if implemented, would have the C-suite camping out in the contact center and inviting customers to board meetings.

The demand for quality assurance and quality control managers in the manufacturing sector has never been stronger, according to Patrick O’Rahilly, founder of FactoryFix.

Today I’m looking at the ideas inspired by mirror neurons. Mirror neurons are a class of neurons that activate when someone engages in an activity, or when they observe the same activity being performed by someone else.