Introduction to the In-Vitro Diagnostic Regulation (IVDR)

  • 07-08 Mar 2024
  • 24-25 Jul 2024
  • 05-08 Nov 2024
  • Webinar

Description

Introduction to the In-Vitro Diagnostic Regulation (IVDR) is a course dedicated to requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746.

Introduction to the In-Vitro Diagnostic Regulation (IVDR) covers topics such as:

  • How the role of the Notified Body will change under the IVD regulation
  • The new IVD regulation
  • Planing labelling requirements and strategies
  • The requirements of the Technical Documentation for an IVD
  • How IVDSs are classified
  • The key changes to ISO13485
  • The vigilance and Post Market Surveillance (PMS) requirements for IVDS
  • The requirements for clinical evidence

Introduction to the In-Vitro Diagnostic Regulation (IVDR) brings together:

  • Persons responsible for regulatory compliance
  • Regulatory affairs personnel
  • Those responsible for OEM/Subcontractor control of IVDs
  • Quality assurance professionals
  • Economic operators, importers, distributors

Introduction to the In-Vitro Diagnostic Regulation (IVDR) will be held on 07-08 Mar 2024.

More Details

Prices:
1099-1299 Pound Sterling (Estimated)
Early registration date: 03 Oct 2023
Organizer:
Management Forum
Websites:
(07-08 Mar 2024)
(Various dates)

Future Events

Past Events

Important

Please, check "Introduction to the In-Vitro Diagnostic Regulation (IVDR)" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Quality assurance
Government & Global Issues: Law & Regulations
Health & Medicine: Healthcare

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