The deadline for manufacturers to mandatorily comply with MDD 2007/47/EC is finally here. As we all know by now, this is a huge milestone after years of planning, reviewing, and an adoption process that started back in 2005. Now, with 5 years in the making, we are finally to the point where medical device manufacturers […]
When it Comes to Translations, Bend ‘m Like Beckham
Translations and soccer do not seem to have a lot in common at first. But when viewed through the perspective of quality management system ISO 9001, they may have some surprising common ground. With the 2010 World Cup kicking off in just four months in South Africa, soccer fever is starting to rise. Soccer aficionados will be glued […]
Italy Ministry of Health Simplifies Medical Device Registration
Effective February 6, 2010, all medical device manufacturers will need to comply with the Italian Health Ministry’s revised decree that regulates medical device registration. Italy — A New Ministry of Health Decree Should Simplify the Registration Process for Medical Devices The new decree, published on 21 December 2009, replaces the controversial decree of 20 February […]
Understanding European Language Requirements for Medical Devices and Pharmaceuticals
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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