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Eurofins Scientific SE is a French group of laboratories headquartered in Luxembourg, providing testing and support services to the pharmaceutical, food, environmental, agriscience and consumer products industries [1] [4] and to governments.
The United States Occupational Safety and Health Administration (OSHA) requires that 38 different types of products, devices, assemblies, or systems used in the workplace be "approved" (i.e., tested and certified) by third-party organizations identified as Nationally Recognized Testing Laboratories (NRTLs). As part of OSHA's NRTL Program, the ...
In November 2020, Hologic won a $119 million contract from the U.S. Department of Health and Human Services and the Department of Defense to help expand production facilities in three states, Wisconsin, Maine, and California, with the goal to provide 13 million COVID tests per month by January 2022.
Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
Standards for validation and verification of medical laboratories are outlined in the international standard ISO 15189, in addition to national and regional regulations. [1] As per United States federal regulations, the following analytical tests need to be done by a medical laboratory that introduces a new testing device:
Charles River Laboratories International, Inc. is an American pharmaceutical company specializing in a variety of preclinical and clinical laboratory, gene therapy and cell therapy services for the pharmaceutical, medical device and biotechnology industries. [2]
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