medical device classification News
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FDA Establishes New Medical Device Category: FDA Authorization Now Required to Market UV Robots to Healthcare Facilities
The U.S. Food and Drug Administration (“FDA”) has announced a new medical device product classification “whole room microbial reduction device” which establishes FDA regulation of UV robots intended to reduce the number of pathogens in unoccupied patient rooms, operating rooms and other areas in healthcare facilities where non-critical medical devices are present. ...
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BSI group America Inc. Announces specialized regulatory training courses for the healthcare industry
BSI Group America Inc., a leading provider of total solutions for certification and standards announces the launch of Specialized Regulatory Training courses targeted specifically for the medical device industry. Available on-site, these Specialized Regulatory Courses reflect requirements of the latest amendments to the Medical Device Directive enabling attendees to comply efficiently with ...
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