Course code RA1

Introductory course/workshop "Medical Device Directive a Better Understanding" (half a day)

Course description:

This course/workshop is intended to provide a basic introduction to one of the Medical Device Directive(s), the AIMD, MDD or IVD, as per your requirements. It systematically examines Medical Device Directives in the EU and the “New Approach”. Global Harmonization as related to the Medical Device Directives is discussed. The specified Directive is considered in more detail including: the Definition of a Medical Device; the Roles of the Notified Body and Competent Authorities; the Classification Rules and Criteria; the Conformity Assessment Route; Quality Management System requirements; Post Marketing Surveillance and Vigilance requirements; Technical Documentation; Standards and Essential Requirements; Labeling; and Clinical Data.

Practical examples are used to interactively demonstrate various aspects of the Directive.

Course objectives:

• To provide participants with a general overview of the Directives and their requirements
• To clarify the structure of the Medical Device Directive
• To understand the EU classification of Medical Devices
• To provide participants with a basic understanding of the European CE Marking Approach
• To examine the roles of the Notified Body and Competent Authority
• To identify Quality Assurance requirements and other requirements as specified above.

Who should attend:

There are no prerequisites for this course. The course is aimed at:

• Start-up Medical Device Companies
• Medical Device Companies new to the EU market
• QA/RA Managers
• Senior and Executive Management

Course materials:

Participants will receive a comprehensive course manual with reference materials, and upon successful completion of the course/workshop, a “certificate of attendance”.

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