GMED North America’s Training Center

Technical Documentation per (EU) In Vitro Diagnostic Device Regulation 2017/746

Identify and understand the key elements required in the in vitro diagnostic device technical file

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3 half-days of training | Virtual Classroom | $1500 pp

About the training

The European Union Medical In Vitro Diagnostic Device Regulation– Regulation (EU) 2017/746 (or EU IVDR) – 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 medical in vitro diagnostic device product(s) and:

Gain an understanding of the changes introduced by EU IVDR requirements;

Assess the impacts of those changes on their organizational and structural activities.

REQUIRED LEVEL

Good knowledge and previous implementation 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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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

Day 1 & 2

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

The trainer is very knowledgeable and was able to make comparison with the IVD 98/79/CE and the FDA regulations. The training pace was good. The presentation of the 2017/746 regulation was very clear and gives an accurate overall of it.

Sr. Regulatory Affairs Specialist

All-important requirements of the IVDR are well explained and some examples are given to better understand.

Regulatory Affairs Specialist

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