Objectives

The aim of the course is to identify similarities and differences between the regulations of the FDA and the European regulations for Medical Devices.

The focus will be on: 

• Classification Rules and Submission in the USA
• Certification Procedures
• Technical Documentation vs Device History File and Device Master Record
• Combination Products
• Design Controls
• Validation / Qualification
• Regulatory Audits
• CAPA and Complaint Handling

A Notified Bodies representative will start the course by explaining the regulatory requirements. In the further presentations particular attention will be paid to findings made during FDA inspections. 

3 Parallel Workshops concentrating on technical documentation, classification and submission and audit findings, will provide practical orientation.

Target Group

This event has been especially designed for the manufacturers who are subject to the medical device legislation and want to become familiar with the practice-oriented implementation of the legal requirements in the USA and in Europe.