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 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 […]