Testing and Inspection
Mar 06, 2014
By Mike Ahmadi The advent of computerized medical devices and technologies has led to enormous health benefits. Pacemakers, insulin pumps, and...
Sep 23, 2013
By Jim Dickinson FDA has cited South Korea-based ChungDo Pharm for QSR violations after a March inspection documented several manufacturing problems with the...
Aug 06, 2013
Ultrasound’s sensitivity to material interfaces makes it useful in screening plastic-encapsulated microcircuits (PEMS) and other components used in the...
Jun 03, 2013
 What elements are needed to achieve a successful product launch? First, the product development team should consist of product design engineers,...
May 14, 2013
By Gil Zweig, President, Glenbrook Technologies Over the years, FDA has issued a number of documents that provide guidance for industry and FDA staff, with...
Jan 08, 2013
By following best practices for labeling companies can also take greater advantage of the flexibility offered by electronic labeling.  Image...
Oct 08, 2012
A company produces turnkey leak testing systems for medical device manufacturers wishing to eliminate the risk of releasing products to market that do not...
Sep 13, 2012
A manufacturer of machine vision systems for medical device inspection and traceability has developed an entry-level vision system specifically for inspection...
Aug 15, 2012
Today, manufacturers routinely conduct summative (i.e., validation) usability tests to determine if their medical devices are safe to use “as is,”...
Jul 02, 2012
 A provider of vision equipment to limit liability and provide product consistency to medical device manufacturers has made developments to its product...