IVDR Readiness – prepare for the changes in the new IVDR

WEBINAR

Course description

After this 2-hour webinar you will be better equipped to tackle these questions. We’ll walk you through the key IVDR requirements and provide you with tools to establish a road map for your work towards IVDR compliance.

The requirements posed on specified roles such as importer, distributor and “legal” manufacturer will be discussed as well.

Finally, we will cover how the interrelation between performance evaluation, risk management and post-market surveillance can be demonstrated in your quality system.

Course content

• What are the main differences compared to the IVD (in vitro diagnostic medical devices directive)?
• How do I establish a road map to be compliant?
• Specific items that need my attention?
• What are the timelines regarding product compliance?
• How do I prepare my quality system to be in compliance? Additional requirements?
• Feedback loop between Risk management, Performance evaluation and Post-Market Surveillance?
• What is my responsibility as subcontractor/contract manufacturer towards a legal manufacturer?

Learning objectives

Completion of this course will give you the knowledge needed to assess applicable requirements for IVDR compliance.

Who should attend

The course is suitable for persons involved in, or responsible for product development or regulatory/quality work concerning IVD-devices and who need to know the changes that comes with the implementation of the In Vitro Diagnostic Medical Device Regulation.

Prerequisites

• You should have good knowledge of the quality system within the Medical Device segment.
• You should have at least 2 years of experience within the IVD/medical device industry.

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