IVDR in a nutshell – Technical Documentation

What is required from your technical documentation to achieve CE-certificate for your in-vitro diagnostic devices? How do I manage the coordination between GSPR, Performance Evaluation and Risk Management? When do I need to perform a Biological Evaluation? What does the Notified Body expect from us? How to deal with Class A devices? This training will give you the answers!

Course description

After this half day training you will be better equipped to tackle the questions above.
We’ll walk you through the key IVDR requirements on your Technical Documentation and provide you with tools whether you need to perform a gap analysis of an existing Technical File, or start from scratch.

To get the full understanding of IVDR requirements on Quality Management System, Risk Management and the Technical File – combine this course with:

• IVDR in a nutshell – the Quality Management System
• IVDR in a nutshell – Risk Management

Course outline

• The intent of IVDR – key elements of the regulation, to achieve increased patient safety.
• The “Intended use” and its impact on risk management and performance evaluation
• Performance evaluation  – purpose, scope, and the importance of “state-of-the-art”.
• Risk Management (RM)– how to manage legacy products and how to integrate risk management in a design & development project.
• Post-Market Surveillance/ Post-Market Performance Follow-up, and it’s relation to Performance Evaluation and Risk Management

Learning objectives

Completion of this course will give you the knowledge needed to assess and update your current technical documentation for IVDR compliance.

You will learn how to:

• Perform a gap analysis of your current technical file, in relation to IVDR.
• Demonstrate compliance to GSPR
• (Write a PMS plan)
• Interact with the NB

Who should attend

The course is suitable for persons involved in Design & Development of In-Vitro Diagnostic devices, or writing or maintaing Technical Documenation, such as: Design engineers, Head of R&D, Regulatory Affairs Managers or Specialists, or Quality specialists/Engineers.

Prerequisites

• You should have knowledge of medical device quality systems from working with IVDD and/or ISO13485.
• You should have at least 2 years of experience from the medical device industry.

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