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In the European Union, for instance, manufacturers must obtain the pre-market CE mark compliance label for their products, and to otherwise make sure they meet the requirements of applicable directives. These include the Medical Devices Directive (MDD) (Directive 93/42/EEC), the Active Implantable Medical Devices Directive (AIMDD) (Directive 90/385/EEC), and the In Vitro Diagnostic Directive (IVDD) (Directive 98/79/EC). In individual European countries, specific national laws may also need to be considered.
Similar situation exists in other markets, be it those that form part of the Global Harmonization Task Force (GHTF) (Australia, Canada, Japan, and the USA, complementing the EU), or the many nations that are outside the EU and GHTF, such as China, with regulations set by the Chinese State Food and Drug Administration (SFDA), Russia and Brazil.
Key Related Directives and Regulations
Medical Devices Directive (MDD)
Active Implantable Medical Devices (AIMDD)
In Vitro Diagnostic Directive (IVDD)
Managing regulatory compliance is one of the most critical aspects for medical device companies to deal with. Even a minor mistake can delay regulatory approval and push back a product launch.
Quality errors in translations - in addition to generating extra costs for correction - can also result in product delays, product recalls, and in some cases can even lead to product liability lawsuits.
All this puts an additional responsibility on managers at medical companies as they choose their translation services providers.
At Moravia we realize the importance of providing you with a dependable and comprehensive solution, which allows you to focus on the product, while we take care of your language needs. Moravia Worldwide has the expertise to provide you with the infrastructure for achieving faster time-to-market and high quality translations, throughout the complete medical device product lifecycle: