The global demand for medical devices has been steady in traditional markets despite the economic downturn and even increasing in some emerging markets.

Editor's note: Lisa Greenleaf will be appearing on the May 4, 2012, episode of Quality Digest Live at 11 a.m. Pacific, 2 p.m. Eastern.

Compliance is an unfortunate word in connection with standards because it suggests something arduous, unpleasant, costly, and annoying that one must do to “get the certificate.”

The great artist and inventor Leonardo da Vinci once said, “Simplicity is the ultimate sophistication.” National Institute of Standards and Technology (NIST) research engineer Javier Atencia certainly believes in the wisdom of what da Vinci preached; he has a reputat

BusinessAssurance.com, the world’s first online management systems community, which is sponsored by Lloyd’s Register Quality Assurance Inc., brings to you an interview with Mike Toffel, a leading management systems expert and an associat

There are substantial changes in the third edition of IEC 60601-1, and understanding all aspects of them is the key to turning the standard into a benefit for medical-device manufacturers.

An advance in sensor design by researchers at the National Institute of Standards and Technology (NIST) and the University of Waterloo’s Institute of Quantum Computing (IQC) could unshackle a powerful, yet high-maintenance technique for exploring materials.

Much has been written and discussed about “risk” being the future of “quality.” But what does this really mean, and how does it work?

The ISO 9001 requirements pertaining to preventive action would get a lot more attention if people grasped the very simple fact that this is all about managing risk—which is really about managing the consequences of change.