FDA Compliance Features

Jennifer Sprance's picture
Jennifer Sprance
The molecular diagnostics industry is a relatively new territory that offers much promise for early disease detection and personalized patient care. When analyzing samples at the molecular level,...
Benny Shaviv's picture
Benny Shaviv
The rapid pace of technological advancement in the last decade has introduced both significant benefits as well as significant challenges to medical device makers. Companies these days are faced...
Malcolm Chisholm's picture
Malcolm Chisholm
I have just finished rereading Walter A. Shewhart's 1939 book Statistical Method from the Viewpoint of Quality Control (Dover Publications, 1986). Mine is the 1986 edition, which has a foreword by W...
Mike Richman's picture
Mike Richman
Here at Quality Digest, we get a lot of mail: Some of it’s critical, some of it’s praiseworthy, some of it’s cantankerous, and some of it’s challenging. All of it is insightful. And then, every once...
Joby George's picture
Joby George
The FDA’s Center for Devices and Radiological Health (CDRH) posted a notice of draft guidance that will require all medical device adverse-event reports to be submitted electronically. While the...
Steve Arbogast's picture
Steve Arbogast
A quality management system is a framework of processes and procedures that are used to ensure that an organization can fulfill all tasks required to achieve its goals, strategies, and objectives...
GKS Global Services's picture
GKS Global Services
In this case study of reverse engineering and rapid prototyping we will look at a company that developed an initial prototype of an anti-snoring device based on many years of research in the field...
Georgia Institute of Technology's picture
Georgia Institute of Technology
Radio frequency identification (RFID) systems are widely used for applications that include inventory management, package tracking, toll collection, passport identification, and airport luggage...
John Stiller's picture
John Stiller
 Story update 9/23/09: Reference to 9.5.2.f was changed to 8.5.2.f in second paragraph. As more suppliers are required by their regulators and customers to achieve ISO 9001 certification, and...
Matthew J. Savage's picture
Matthew J. Savage
As companies downsize, they cut down on the number of employees, or move, or close, and thousands find themselves without jobs in a highly competitive job market that they never anticipated. A 55-...
Anonymous's picture
William R. Pape and Richard Ross
Resistance to the National Animal Identification Scheme (NAIS) has been strong. This six-year-old USDA policy initiative to reduce the catastrophic effects to the livestock and meat industry from...
Bill Kalmar's picture
Bill Kalmar
The band “Chicago” sang those words about "time" decades ago. The second line “Does anybody really care?” seems to sum up what is still in vogue today, especially in the workplace. Just as...
David C. Crosby's picture
David C. Crosby
When I say quality manager, of course I’m talking about the department he or she manages as well. I’ve been in the “quality business” for fifty years now. That’s right, fifty years. Much of my...
Richard A. Vincins's picture
Richard A. Vincins
Through the 1990s, the application of a quality system relied primarily upon the Food and Drug Administrations’ (FDA) good manufacturing practice requirements or the FDA 21 CFR Part 820 Quality...
H. James Harrington's picture
H. James Harrington
I often get assignments at organizations where I am required to take aside a group of people, either within the building facility or off campus, to focus on issues or problems. Typically these...
David C. Crosby's picture
David C. Crosby
The most important element in producing a quality product or service is the attitude of the people doing the work—not only the worker—but the attitude of all levels of management. Employee attitude...
Minitab LLC's picture
Minitab LLC
A $1 billion annual budget may sound ample, but a few years ago, the costs of services ranging from law enforcement to cleaning county buildings had squeezed the government of Erie County, New York...
Dale Hershfield's picture
Dale Hershfield
Twitter is the latest new thing. Want to follow John McCain or Al Gore throughout their day? Easy. Just sign up to receive their tweets. While their tweets may provide insights, or just...
Craig Cochran's picture
Craig Cochran
When I first got into quality, I really hated verifying the effectiveness of actions taken to correct a problem. After all, I was young and inexperienced. All of the people whose actions I was...
Mark Symonds's picture
Mark Symonds
It’s no secret to anyone, anywhere, that we’re experiencing a global business challenge, especially in manufacturing. One could argue that for too long, manufacturers in the United States have...