Linda Horton says changes won't affect U.S. companies much. Although changes to the European Union's Medical Devices Directives probably won't involve a major overhaul of the regulations or the system ...
Stereotaxis Inc. recently received CE mark recertification for all its devices currently available in Europe under the new Medical Device Regulation (MDR) regulatory framework. The MDR has replaced ...
The nation’s cyber defense agency is requiring all federal civilian agencies to remove such devices from their networks. The Cybersecurity and Infrastructure Security Agency has issued a new binding ...
As is already the case under the current EU Medical Device Directive 93/42/EEC (as amended by Directive 2007/47/EC – “MDD”), the purpose for which the software is intended to be used is and remains ...
LAUSANNE, Switzerland--(BUSINESS WIRE)--Neo Medical SA (Neo), a Swiss technology company specializing in spine surgery, today announced the approval of its entire product portfolio under the European ...
The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.
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