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CE Marking for the EU Medical Device Directives
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Course
0700
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2
Days
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1.4
CEUs
Call for pricing at your location.
“Very useful course and right on target! The instructor was excellent, drawing upon invaluable direct experiences.”
-–Stephen Page, Director of Regulatory Affairs, Genzyme Surgical Products, Inc
Key Session Topics
- How to plan for the European approval process
- History, objectives and structure of the EU Directives and related directives
- Essential safety requirements for CE Marking
- EN Medical Device safety Assessment procedure
- How to combine ISO 9000/ISO 13485 using Medical Device guidance documents (EN 50103, EN 928) with EN ISO 9004-1
- How to develop an EU Medical Device vigilance program
- Key relationships between EU Medical Device Directives, ISO 9000/ISO 13485, conformity assessment procedures and the QSR
- How to choose a notified body for the IVDD standards
- How to select a Conformity
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Why SAI Global?
- Our courses teach real-world business objectives in an
interactive learning environment.
- Our instructors have an average of 20 years industry experience.
- We offer excellent customer service.
- We have maintained a 98.9% approval rating among more than 200,000
training participants.
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submit a
Course Information
Request
or call us at 1-800-374-3818.
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Course Objectives
This two-day course provides an overview of the following EU Directives: Active Implantable Medical Device Directive (AIMDD), Medical Device Directive, and the In Vitro Diagnostic Device Directive (IVDD). Related EU directives Electromagnetic Compatibility (EMC), Product Liability and Product Safety are also examined.
Who Should Attend
- Corporate legal & regulatory affairs
- R&D managers/engineers
- RA/QA managers/engineers
- Management representatives
- Members of multi-discipline design teams
- Sales and marketing management
- Product, project, program managers
- Internal auditors
Prerequisites
There are no specific prerequisites for this course.
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