European in Vitro Diagnostic Devices Regulation (EU) 2017/746
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About the training
The European Regulations on In Vitro Diagnostic Devices– IVDR EU 2017/746 – entered into force on May 26th, 2017. GMED North America has designed a comprehensive training course to help companies get ready for their application to obtain and/or maintain CE marking for their in vitro diagnostic device product(s) and:
- Gain an understanding of the changes introduced by European In Vitro Diagnostic Device Regulation – IVDR EU 2017/746;
- Assess the impacts of those changes on their organizational and structural activities.
REQUIRED LEVEL
Good knowledge and effective practice of the Directives 98/79/EC.
Haijuan Li, PhD, MBA, RAC (US) Product Reviewer and Lead Auditor, GMED North America
Dr. Haijuan (Jane) Li is an accomplished IVD expert in both product development and worldwide regulatory compliance implementation in clinical diagnostics. Jane has 20 years of R&D experience in senior management and technical roles at several well-known diagnostics companies including Roche Diagnostics, Bio-Rad Laboratories, Siemens Healthcare Diagnostics and Thermo Fisher Scientific and 5 years of experience at notified bodies as lead auditor and product reviewer. Jane has designed, developed and launched many IVD and companion diagnostics devices in the US, EU and worldwide.
Jane is currently a product reviewer and lead auditor for IVD devices at GMED North America. Jane holds a Ph.D. in Biochemistry from Rutgers University (New Jersey, USA) and an MBA from Anderson University (Indiana, USA). Jane has been earned the RAC (US) certification since 2013.
Who Should Attend
- Medical Device Manufacturers: Senior Management , Regulatory Affairs Managers and Quality Managers, R&D specialists, Development, Manufacturing and Marketing Managers
- Internal and external Auditors
- Importers
- Distributors
Learning Objectives
- Identify the major changes between the Directive and Regulation
- Understand the structure of the Regulation
- Understand the new requirements of the Regulation
Educational Resources
- Presentations
- Practical working sessions
- Course evaluation
Check out the Program
- Regulation structure
- Scope and Definitions
- Actors and Responsibilities
- Device Classification Criteria
- General safety and performance requirements
- Conformity Assessment routes
- UDI
- Performance evaluation
- Method of proof
- Specific procedure
- Post Market Surveillance
- Requirements for the Vigilance system
- Eudamed
- Transitional arrangements
- Practical working sessions
- Group workshop
- Course Evaluation
- Summary and Discussion with the trainer
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