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Are You Ready for MDD Amendment Directive 2007/47/EC?
Wednesday Jan 27, 2010, 2:00pm – 3:00pm Eastern Time, 60 minutes
Get a $50 discount ($199 after discount) for this event by using the special promotion code AF2009EIS when you sign up at the FX conferences website
Audio conference highlights
Time is running out – ease your MDD compliance strategy stress with detailed guidance from Leo Eisner!
The revised MDD 93/42/EEC comes into effect on March 21, 2010 and the changes will impact all medical device manufacturers that CE mark their products or plan to do so in future. There is no transition date for the amendment 2007/47/EC and if you are not in line with these new requirements by the implementation date, you could lose your CE mark certificate from your notified body.
In this audio conference, Leo Eisner provides an overview of the 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 presentation also covers how the New Machinery Directive and the Personal Protective Device Directive work in concert with the MDD Amendment.
This audio conference covers:
- Major areas of change in the amended Medical Device Directive
- The drivers for this change
- Things your notified body may ask for during an audit
- Determining what areas of your system may be impacted
- The interplay between the revised MDD and other EU directives
Who should attend?
- Regulatory Affairs
- Quality Assurance
- Operations/Manufacturing
- Managing Directors
- Senior Management
Sign-up for the audio conference right here and use promo code AF2009EIS for a $50 discount on this event only