Revision To The Medical Device Directives

BENEFITS IN ATTENDING:

• Clarify the Key Revision Changes
• Consider Aspects of the Recast
• Discuss the New Approach , the Revision and its Implications
• Comply with the New Classification of Devices
• Discover How the Revision will Affect Notified Body Audits
• Plan for Changes to Vigilance and PMS Reporting
• Understand what the Requirements are for a Modified Approach to Clinical Data Be Prepared for the New Mechanism for Reclassification of Devices
• Consider the Changes to Risk Management Strategies
• Understand the Impact on Drug / Device Combinations

ARE YOU PREPARED FOR THE CHANGES?
The revision to the Medical Device Directives is being implemented across the EU. This seminar will examine the changes and their impact on the Medical Device industry including: Reclassification, Clinical Data, Performance of Notified Bodies, Advanced Therapy Medical Devices and Risk Management. In addition the Revision of New Approach Legislation will be discussed.
This will be an excellent opportunity to understand the implications of the regulatory changes and how they will affect your working practices.
WHO SHOULD ATTEND
Managers and Heads of Departments within Medical Device Companies from Regulatory Affairs, Quality Assurance, Clinical Research, Product Design and Development, Standards, Vigilance and PMS.