;   Medical Translation Insight: Are you complying with the latest Medical Device Directive amendment? - ForeignExchange Translations

The revised MDD 93/42/EEC went into effect a little over a year ago, having an impact on all medical device manufacturers that CE mark their products. There was no transition period for the amendment 2007/47/EC and many companies are still struggling with some of the new requirements and risk losing their CE mark certificate from their notified body if they are not in compliance.

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.


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