European in Vitro Diagnostic Devices Regulation (EU) 2017/746
2-day training session

2-day training session
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:
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.
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