Quality Assurance/Quality Control
Medical Device Safety System Design: A Systematic Approach
Jan 24, 2012
As technology advances, medical devices that improve disease diagnosis and the treatment of illness or injury are introduced. Many of these lifesaving medical...
CDRH Report: The Barriers to Quality
Dec 19, 2011
A CDRH report says greater visibility on the agency’s expectations of device quality and properly aligning its regulatory approach are needed to...
MDDI 2011 Salary Survey: Quality Assurance and Quality Control
Nov 29, 2011
Quality Assurance and Quality Control Compensation Profile Thirty-seven percent of respondents in quality assurance and quality control earn $100,000 or more...
Next Generation of TrackWise Enterprise Quality Management Software Reduces Administrative Burden, Increases Efficiency
Oct 07, 2011
Sparta Systems recently announced a set of enhanced web services capabilities for its TrackWise enterprise quality management software (EQMS).  The new...
Digital Force Gauges Designed for Quality Control, Manufacturing, and R&D Operations
Jul 28, 2011
A series of digital force gauges is designed for conducting tension and compression force testing in QC, manufacturing, and R&D departments. Series 3 is...
Theft of Boston Scientific Devices Likely an Anomaly
May 27, 2011
When one thinks of the things thieves usually steal, medical devices do not usually come to mind. Some no-goodniks were apparently thinking outside of the box...
Size Estimation Charts Find Dirt and Defects in Industrial Materials
May 23, 2011
Medical device manufacturers can implement a size estimation chart during the quality control process to find dirt and defects in industrial materials. The...
MD&M East 2011 Preview: Making Devices for the People
May 04, 2011
For all of the aseptic technical details and analytical thinking that goes into developing medical devices, it’s a fundamentally human enterprise. Humans...
Collateral Standards for IEC 60601-1
Apr 27, 2011
Collateral Standards The general requirements of 60601-1 apply to all medical electrical equipment and part 2 standards apply to specific categories of medical...
Is the Third Edition of 60601 the End of Objective Evidence?
Apr 27, 2011
Although the transition period for the third edition of the medical electrical equipment standard (IEC 60601-1:2005) doesn’t end until 2012, there are...