-1.png?length=1000&name=image-mckp%20(1)-1.png)
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
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
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
Register Now
