Written by ForeignExchange Translations on Tuesday, July 12, 2011
In cooperation with one of our partners, Leo Eisner, we have prepared a white paper that provides a comprehensive overview of last year’s changes to the MDD, including changes to definitions, the essential requirements, technical documentation requirements, classification rules, labeling requirements, and new requirements for usability (user error) and clinical data.
The paper also covers how the New Machinery Directive and the Personal Protective Device Directive work in concert with the MDD Amendment. Download the white paper from our web site.
ForeignExchange Translations provides specialized software translation and localization services to medical device companies. Contact us to learn more.