Testing Services
May 16, 2017
Medical device designers should consider including packaging in their human factors studies.     Stephen Wilcox Human factors studies are...
Dec 20, 2016
The main theme running through FDA's guidance on ISO 10993-1 is that every medical device should be assessed for its specific risk to the end user. ...
Oct 03, 2016
Extractable/leachable chemistry testing can save, time, money, and animal life for certain classes of devices. Matthew R. Jorgensen, PhD Over the past decade...
May 05, 2016
Radiofrequency wireless devices must undergo rigorous testing and certification, but there are things manufacturers can do to make the process go smoothly....
Feb 01, 2016
Experts trace the harmonization of Japanese, FDA, and ISO guidelines on biocompatibility testing, as well as key disparities to know. Zhenghong Tao, Laurence...
Jan 20, 2016
Several noteworthy changes are anticipated in a new FDA guidance document on biological evaluation and biocompatibility testing of medical devices due out...
Jul 27, 2015
William A. Hyman Understanding how a medical device will perform during its actual use is a fundamental engineering, patient-safety and risk-management...
Aug 12, 2014
By Mike Neilson A technician wipes a touch screen monitor with a lint-free cloth during a disinfection validation. When you hear the term “...
Aug 05, 2014
Major medical device makers are expecting more clinical trials as they expand into emerging markets and have common strategies and expectations around the...
Apr 21, 2014
Kieran T. Gallahue, Chairman and CEO, CareFusion [Photo Courtesy of CareFusion] Gallague made $9.6 million in 2013, a drop of 3.4% from what he made the year...