Understanding European language requirements for medical devices and pharmaceuticals is crucial as countries within Europe have specific translation requirements for computer software, Instructions for Use (IFU), packaging, and other Medical Device and Pharmaceutical labeling. In this ever-changing regulatory and international market clearance environment, it is vitally important for you to have this information at your […]
Achieving compliance with new European Medical Device Directive
Mandatory compliance is less than a year away (March 2010). There is a buzz about the industry as we close in on the deadline to comply with the new requirements of the European Medical Device Directive. Directive 2007/47/EC drafted September 5, 2007 will amend Directives 90/385/EEC, 93/42/EEC, and 98/8/EC and will be a mandatory requirement […]
Labeling: The Path to Global Market Clearance
Labeling Impact on Worldwide Market Clearance There are a few methods manufacturers can use to properly label their products and successfully gain market clearances worldwide. These different methods require consideration of the time, cost, and risk involved for your company. Common to all of them is the requirement for translation of the labeling. For all […]
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