How to Prepare for IVDR

FREE ON-DEMAND WEBINAR:
October 20, 2022

How to Prepare for IVDR

The European In Vitro Diagnostic Regulation (EU IVDR) entered into application on May 26, 2022. However, Climedo Health and TRIGA-S Scientific Solutions conducted a survey of manufacturers just a few weeks before the date of application and found that:

• 85% of respondents were still “in the
middle” of preparation for regulations

• 43% of respondents still did not have a notified body

• Less than two-thirds of respondents knew the responsibilities
regarding postmarket surveillance and vigilance

The delays, confusion, and shortage of notified bodies have not made it easy for companies to get their QMS and technical documentation compliant with IVDR. That’s why we’ve teamed up with Rook Quality Systems for this in-depth webinar on steps you can take right now to prepare for the new regulation.

This educational webinar, presented by Kyle Rose, President of Rook Quality Systems, will provide you with pertinent details and established best practices on how to prepare your QMS, technical, and clinical documentation for the upcoming IVDR regulations.

Watch the webinar

Specifically, this webinar will:

Provide a detailed breakdown of what is needed to get your QMS in compliance for the IVDR regulations.
Discuss which devices fall under IVDR, including software that provides diagnostic results.
Outline what is required for your clinical and technical files, and how to prepare if you have gaps.
Breakdown the process and timeline for getting a notified body, and what to expect for your audit and technical documentation review.
Highlight key dates for IVDR compliance, and when to start preparing.

Who should attend?

IVD medical device companies interested in learning about IVDR, which replaces the EU In Vitro Diagnostics Directive (IVDD) 98/79/EC

Hosted by

Presenter: Kyle Rose

President,
Rook Quality Systems

Moderator: Etienne Nichols

Medical Device Guru & Community Manager, Greenlight Guru

Rook Quality Systems provides specialized and custom consulting services for all classes of medical devices. We work with you to outline your quality and business goals to develop innovative and efficient practices that improve compliance and profit. You can see a full list of the service offerings from Rook Quality Systems by visiting their website to learn more

About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more

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