The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible.

Although the “new approach” to regulating medical devices has always given more urgency to higher-risk medical devices, this is not the case for the European Medical Device Regulation (MDR).

During the early 1980s, GM, Ford, and Chrysler established the Automotive Industry Action Group (AIAG), a not-for-profit organization with the mission “To improve its members’ competitiveness through a cooperative effort of North American vehicle manufacturers and th

A frog the size of a fingernail. A poncho-clad farmer leading his mule. A tree, some intertwining leaves, a silhouetted figure holding a pot.

Well over half the world’s population does not have access to safe sanitation. For many people, this means the indignity and risks that come of having no toilets. The answer, it seems, lies in new sustainable treatment plants.

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with

The term “risk-based thinking” (RBT) is familiar to those in the quality profession. This familiarity comes in part from its inclusion in ISO 9001:2015, the International Organization for Standardization (ISO) quality management system standard.

In the article, “ANSI’s Role in the Wide World of Standards,” (Quality Digest, March 12, 2019), we looked at where standards originate and how companies a

The AS9100 family of standards has completed very important updates, raising the business management quality bar again for aerospace and defense suppliers and OEMs.

Almost 70 percent of American mothers with children younger than 18 work for pay, but motherhood remains disruptive for many women’s work lives.