This course will clarify the requirements applicable for IVDs and will highlight the important issues regarding supplier control and validation. Practical workshop exercises throughout the day will help consolidate the information provided.
Key Topics to Include:
Introduction to the IVD Directive
What is and What is Not an IVD
Exercise
Comparison with the MDD
Future Changes to the IVDD
Conformity with the Essential Requirements
Risk Management
Exercise
IVD Hot topics
Supplier control
Validation
Exercise
Vigilance and Post Market Surveillance
Exercise
Wrap Up
Who Should Attend:
Regulatory Affairs Personnel
Quality Assurance Professionals
Those responsible for Original Equipment Manufacturer (OEM)/Subcontractor control of IVDs
Past Events
IN-VITRO DIAGNOSTICS 2011 - Feb 2011, London, United Kingdom (10819)
Important
Please, check "IN-VITRO DIAGNOSTICS" official website for possible changes, before making any traveling arrangements
