medical device & ivd: iso 13485 regulatory compliance masterclass
DESCRIPTION
Objectives: • Understand the Structure of the In Vitro Devices Directive • Understand EU Classification of In Vitro Devices • Establish an Understanding of the European CE Marking Approach • Identify Quality Assurance Requirements for Medical Devices Sold to Europe • Recognize the Role of Standards, Essential Requirements, and Labeling • Understand Risk Management • Value Post Market Surveillance and Vigilance • Understand impact of changes to the IVD Directive in view of 2007/47/EC Trainers: Tony Low Regulatory Compliance and Management Systems Specialist QUE Standards Consultany Kerri-Anne Mallet MBA Project Leader Voisin ConsultancyTRANSCRIPT
