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European in Vitro Diagnostic Devices Regulation (EU) 2017/746
European in Vitro Diagnostic Devices Regulation (EU) 2017/746; 2-day online training session; May 9-10, 2023.
When and where
Date and time
May 9 · 7am - May 10 · 3pm PDT
Location
Online
Refund Policy
About this event
- 1 day 8 hours
- Mobile eTicket
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.
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
RESOURCES
- Presentations
- Practical working sessions
- Course evaluation
AGENDA
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
About the Trainer
Haijuan (Jane) Li, PhD, MBA, RAC (US), Product reviewer & Lead auditor at GMED NA
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.
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About the organizer
GMED North America. is the subsidiary of GMED, leading Certification Organization & distinguished Notified Body (CE0459).
GMED is a leading Certification Organization and a distinguished Notified Body (CE0459) whose scope covers all of the existing European Medical Device Directives (90/385/EEC, 93/42/EEC and 98/79/EC).
GMED is also an Auditing Organization Recognized by the MDSAP Regulatory Authority Council and has been performing MDSAP audits since April 2015. GMED is accredited under the NF EN IEC/ISO 17021-1:2015 standard by COFRAC (Certificate № 4-0608), the French Accreditation Committee, to carry out Quality Management System Certification activities according to ISO 9001:2015 and ISO 13485:2016.
Established in 1994, GMED is fully owned by LNE (e.1901), a State owned Industrial and Commercial Establishment (EPIC), and operates since August 1st, 2018 as a simplified joint stock company (SAS) within the LNE group.
GMED’s success and high level of performance rely first and foremost on a strong and dedicated team of individuals trained at the highest level of the current evaluation and auditing methods to provide the best certification services: Certification Project Managers, Subject Matters Specialists (MDAO or Medical Device Animal Origin, Medicinal Substance, Active Implantable Medical Devices, Microbiologists), Technical Documentation Evaluators and Design Dossier Assessors, Clinical Reviewers & Experts (Ex: Sterilization Methods and Validation) and Auditors for CE marking and QMS activities.
With offices in Europe and a dedicated US Operation created in 2005 - GMED North America (MD), GMED offers the convenience and efficiency of local teams of experimented specialists to accompany your certification process which will allow you to market in your target markets.