medical device testing service News
-
Fretting Corrosion Causes Recall of Drug Delivery Medical Device
This past November, the U.S. Food and Drug Administration (FDA) announced a Class 1 recall of the Ikaria INOmax DS Drug Delivery System. The device is a drug delivery system used with ventilators to deliver a preset concentration of INOmax therapy gas (nitric oxide for inhalation) for critically ill patients. According to the FDA posting regarding the recall, “Fretting corrosion at the ...
-
STEMart Launches New Force Degradation Services to Ensure Drug Stability and Safety
STEMart, a US-based provider of comprehensive services for all phases of medical device development, announced the launch of its new Force Degradation Services to help pharmaceutical and medical device companies evaluate the stability of their drug candidates and finished products under a variety of stress conditions, ensuring their safety and efficacy throughout their shelf life. Forced ...
By STEMart
-
STEMart Launches Bioburden and Sterility Testing for Medical Devices
STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced the Bioburden and Sterility Testing services for medical devices under the guidance of the ISO 11731 method. For medical device manufacturers, sterility assurance is a vital part in producing safe products. The FDA and other regulatory agencies require validation of ...
By STEMart
-
STEMart Launches Pyrogenicity Testing Service for Medical Devices
STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, now launches Pyrogenicity Testing service for the medical device industry. This new testing follows the biocompatibility guidelines modified for medical devices. Due to the risks associated with medical devices, comprehensive medical device testing throughout the product ...
By STEMart
-
STEMart Launches Microbiology & Sterility Testing Services for Medical Devices
STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, introduces comprehensive microbiology and sterility testing for sterile, non-pyrogenic products. STEMart has extensive expertise in microbiology as well as sterility testing and remains dedicated to a full-service experience that supports manufacturers in meeting ...
By STEMart
-
STEMart Launches Biological Indicator Sterility Testing Service for Medical Devices
STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced Biological Indicator Sterility Testing services for the industry of medical devices. This testing is performed according to the exposure of Biological Indicators (BIs) after completion of the sterilization load, and it is a qualitative test to reveal results that can ...
By STEMart
-
Bemis, DDL, Earth911 and Heinz Join the American Institute for Packaging and the Environment (AMERIPEN)
The American Institute for Packaging and the Environment (AMERIPEN) announced that four additional companies in the packaging value chain have joined the organization as Voting Members: Bemis Company, Inc., an international supplier of flexible packaging and pressure-sensitive materials; DDL, a medical device product, packaging and materials testing services ...
By Ameripen
Need help finding the right suppliers? Try XPRT Sourcing. Let the XPRTs do the work for you