IVDR and requirements on the Quality Management System

– What are the requirements on legal manufacturers to achieve CE-certification for in-vitro diagnostic devices?
– What will the NB need look for when auditing our Quality Management System?
– What is the responsibility of the PRRC, in relation to the QMS?

This training will give you the answers!

Course description

After this 1 day training, you will be better equipped to tackle the questions above.
We’ll walk you through the key IVDR requirements on your Quality Management System and provide you with tools to perform a gap analysis and perform an update of your quality management system, to ensure compliance with the IVDR. The relationship between ISO13485:2016 and IVDR, and the role & responsibilities of the PRRC will be clarified.

To get the full understanding of IVDR requirements on Quality Management System, Risk Management and the Technical File.

Course outline

• Understand the impact of IVDR to your quality management system
• Responsibilities of the PRRC – Person Responsible for Regulatory Compliance
• How to utilize ISO13485:2016 to ensure compliance to the regulation.
• Assess and audit your internal quality management system against IVDR

Learning objectives

Completion of this course will give you the knowledge needed to assess and update your current quality management system for IVDR compliance, make use of ISO13485:2016 to manage key regulatory requirements and apply a risk-based approach.

Who should attend

Quality Managers, the PRRC (Person Responsible for Regulatory Compliance), the Management Representative, of an IVD Manufacturer.  Quality Specialists/ Engineers, RA Managers/Specialists, Persons involved in Design & Development,  writing or maintaining Technical Documentation, such as: Design and development engineers,  Quality representatives in design and development projects, or the Head of R&D.

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.

#5138