BSI's "European Medical Devices Directive Requirements" course is designed to provide a toplevel overview of the guidelines of the European Medical Device Directives MDD 93/42/EEC and comprehensive information on the MDD 2007/47 changes. Personnel responsible for quality systems for medical device manufacturers will benefit from this overview course which focuses on the 2007/47 changes to the European Medical Device Directive and the effect on organizations when placing medical devices in the European market. An experienced instructor will lead participants through exercises and discussion points.

Learning objectives:

• The European CE Marking Approach to Regulated Products
• The structure of the Medical Devices Directive 93/42
• The classification and conformity assessment routes
• The steps in CE marking

Course materials:

Students receive comprehensive course manuals with reference materials.

Who should attend:

• Decision makers on quality management system strategy at medical device manufacturing organizations
• Quality personnel in organizations interested in entering foreign markets
• Management team members of medical device manufacturers
• Quality managers in the medical device industry
• Internal and external auditors of medical device manufacturing firms

Prerequisite:

General awareness of ISO 13485:2003 and experience in a medical device manufacturing environment is recommended.

Course logistics:

Certificates of attendance are provided at the conclusion of the course.

Student : Instructor Ratio - 20:1