January 17, 2019 - January 17, 2019
Date: 17 January 2019
Duration: 1 Day
Location: Silicon Valley
Cost: Regular $ 990.-
The new EU-IVDR brings about many changes, including many definitions, new conformity assessment routes, new Notified Body designations and more. On top of that, there is a completely revised rule-based classification system and stricter requirements for safety and on analytical and clinical performance. Much more details have been included in the general safety and performance requirements replacing the current essential principles of the Directive, and above all: no grandfathering.
This training focusses on practical guidance to implement IVDR from determining the gaps from your current documentation and processes and the IVDR requirements. Gap assessments in QMS, technical files and analytical and clinical performance will be necessary to comprehend the scope of implementation required in your organization.
The training will clarify the new classification rules in detail and provide methods to determine the impact of the regulation through product portfolio review and prioritization. High level project planning will be included. The day will be filled with discussions and case-studies.
Highlight of changes in EU IVD Regulation (IVDR) from current IVD Directive (IVDD)
New classification system
Essence of gap assessment of technical documentation
Essence of gap assessment of QMS
Essence of gap assessment of performance evaluation and clinical evidence
Product portfolio review
High level implementation plan
Questions & Answers
Evaluation of the Course and Closing
Learn to correctly classify the IVDs under the new IVDR rule-based system
Learn to perform various gap assessments at start of IVDR project
Learn to reflect on the product portfolio
Learn to structure an implementation project
Understand how to build and use assessment lists, tools and templates
Who should attend:
RA manager, RA director, QA manager, QA director, Clinical director, R&D/Product Development Manager, Marketing manager, Operations Manager, international registration department