Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

This seminar provides an essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow up requirements and adverse event and vigilance reporting for medical device clinical studies complying with the European Medical Device Directive 93/42/EEC. It will provide a good introduction to medical device clinical studies and serve as an update for those with experience who need to keep abreast of the regulatory changes and the methods of handling adverse events during the study period.

By attending this meeting you will:

• HEAR all you need to know about the regulatory requirements for monitoring and reporting adverse events in one information packed day
• FIND OUT when a clinical investigation is need
• DISCOVER the requirements for vigilance reporting
• UNDERSTAND the main changes involved with the new Medical Device Regulations
• APPRECIATE the role of The Competent Authority and how to, when to, and what to communicate with the authority

• Regulatory affairs specialists
• Quality assurance specialists
• Clinical research associates
• Junior clinical research associates