An Introduction to the Medical Device Regulation

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Directives and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do. It will also cover the documentation necessary to apply for the CE Mark.

This is an excellent introduction from leading experts in the field and delegates should expect three comprehensive days of training.

An Introduction to the Medical Device Directives ~ this course will help you gain a comprehensive understanding of the regulatory requirements.

BENEFITS OF ATTENDING

• Learn the role of a Notified Body
• Know what a Competent Authority expects
• Better under Conformity Assessment Procedures, Classification, Medical Device legislation
• Comply with Manufacturing Responsibilities
• Consider the requirements for Quality Systems
• Plan your Clinical Evaluations

Past delegates include personnel from the following departments:-

• Regulatory Affairs
• Pharmacovigilance
• Quality Assurance
• Technical Support

This seminar will be of interest to all personnel who are new to the medical device industry, all those who intend to place a medical device on the market and anyone who requires an overview of the medical device sector