European in Vitro Diagnostic Devices Regulation (EU) 2017/746
Understand and assess the changes introduced by the Regulation
2-day training session | Virtual Classroom
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.
⇒ VIRTUAL TRAINING BUNDLE:
Save up to $350 by combining this training with “In Vitro Diagnostic Devices Regulation (EU) 2017/746” training.
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Trainers
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 earned the RAC (US) certification since 2013.
Ava Sainter, MPhil
Product Reviewer, LNE-GMED UK
Ava is a distinguished professional in the field of sciences, renowned for her expertise and contributions to the in vitro diagnostics (IVD) industry. With an Honours Degree in Biomedical Sciences and a Master of Philosophy (MPhil) in Translational Medicine from Strathclyde University in Scotland, Ava has over 12 years of research and product development experience in the IVD industry, spanning cancer therapy, infectious diagnostics, women’s healthcare, and hormone monitoring.
Ava is currently a product reviewer at LNE-GMED UK, which ensures compliance with regulatory standards such as the In Vitro Diagnostic Regulation (IVDR) and the In Vitro Diagnostic Directive (IVDD). She is also qualified in ISO 13485 and serves as a UKCA decision maker, guiding critical decisions impacting product safety and market access.
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
- Summary and Discussion with the trainer
Attendees Testimonials
Sr. Regulatory Affairs Specialist
Regulatory Affairs Specialist
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