Technical Documentation per In Vitro Diagnostic Devices Regulation (EU) 2017/746
Identify and understand the key elements required in the in vitro diagnostic device technical file
1.5-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 identify and understand the key elements required to establish their medical technical file as part of their CE marking application process.
REQUIRED LEVEL
Good knowledge and effective practice of the European In Vitro Diagnostic Devices Regulation (EU) 2017/746.
⇒ 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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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 component parts of technical documentation for establishing the conformity of in vitro diagnostic medical devices in line with the requirements of the European Regulation
- Identify the best practices for structuring the technical documentation in line with the expectations of certified bodies and competent authorities in charge of medical devices and market surveillance
Educational Resources
- Presentations
- Practical working sessions
- Course evaluation
Check out the Program
- Overview of regulations, guides and recommendations
- Identification of applicable requirements
- Content of the technical documentation (TD): structured approach
- Requirements for updating the technical documentation
- Management of the technical documentation: responsibilities and updating procedures
- EC Declaration of conformity: output data of the technical documentation
- Summary and Discussion with the trainer
Attendees Testimonials
Sr. Regulatory Affairs Specialist
Regulatory Affairs Specialist
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