The EU has prepared for IVDR for almost 2 years now.
Many of your IVD colleagues say they still are not ready or prepared. Are you?
This full day seminar will provide an in-depth look at the key regulatory aspects along with QMS implementation of the European In Vitro Diagnostic Medical Devices Regulations (IVDR) 2017/746.
It will be of value to anyone working in the In Vitro Medical Device community and anyone marketing or planning to market IVD’s in Europe. The seminar will focus on implementation and participants will receive certification of completion, course materials along with a variety of procedure templates and checklists.
Introduction to EU IVDR - Overview of EU IVDR:
Purpose, Scope, and Objectives,
Key Changes from IVDD to IVDR,
Key Dates for IVDR Implementation
Regulatory Framework - Structure of the EU IVDR:
Requirements and Annexes,
Classification of In Vitro Diagnostic Devices (IVDs)
Pre-Market Requirements –
Conformity Assessment Procedures,
Technical Documentation Requirements
Post-Market Requirements –
Post-Market Surveillance and Vigilance,
Clinical Evaluation and Performance Studies
Registration Fee - $250, buffet lunch, drinks and breaks included.
More information and registration
https://app.memberplanet.com/#/event/asqbiomedicaldivisioncommittee/iv
dr2017746seminar