Medical device labeling is considered as important as classifying a product or creating an insulation diagram. In IEC 60601-1, labeling is deemed "a critical component of a medical device." 1 The ...

A medical device is an umbrella term for any instrument, software, or other article used alone or in combination for a medical purpose in humans. An estimated 2 million different kinds of medical ...

Crimson’s DTP-Free Labeling Solution Specifically Designed for Manufacturers of Stretchers & Beds, Radiological, Imaging, and Other Capital-type Devices "The results we've achieved were so remarkable ...

Tucked away in the Federal Register are the FDA's intentions to test its own labeling format to "inform FDA's planned regulatory approach to standardizing medical device labeling across the United ...

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...

Overview: This webinar will provide valuable assistance and guidance to device companies in involved in labeling changes. FDA recently released a final rule regarding the parameters in which a device ...

Once the U.S. Food and Drug Administration (FDA or “the agency”) has cleared or approved a medical device for marketing in the United States, there are still significant postmarketing requirements ...

PORTSMOUTH, N.H., May 22, 2019 /PRNewswire/ -- Loftware, Inc., the global leader in Enterprise Labeling and Artwork Management Solutions, today announced the availability of Loftware Spectrum for ...

Food and Drug Administration, HHS. The Food and Drug Administration (FDA) is proposing to implement provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require electronic ...

As of August, over 30 medical devices were approved by the US FDA alone, in 2019. Given recent technological advances and the increasing complexity of such products, the need for proper medical device ...