Navigating IVDR compliance: Practical insights and strategies for long-term success

Gain practical insights and expert strategies to achieve and maintain IVDR compliance. Join DNV’s live webinar for IVD manufacturers.

Industry challenges
The transition to the In Vitro Diagnostic Regulation (IVDR) is one of the most significant shifts facing manufacturers and suppliers of IVD products. With stricter requirements, evolving timelines, and increasing documentation demands, organizations often struggle with:

  • Understanding and interpreting IVDR requirements.
  • Preparing robust technical documentation under tight timelines.
  • Managing complex certification processes with notified bodies.
  • Ensuring long-term compliance while keeping pace with market demands.
  • Leveraging digital tools to simplify and strengthen compliance.

This webinar addresses these challenges directly, drawing on DNV’s experience as a notified body and highlighting practical strategies to support long-term success.

What you will gain from this session

  • A clear update on the state of IVDR and upcoming timelines.
  • Insight into the biggest compliance challenges facing IVD companies today, based on our LinkedIn community poll.
  • A step-by-step overview of the certification process, from quote request to contract and certification.
  • Practical examples of how digital tools and data can streamline IVDR readiness, documentation, and reporting.
  • Tailored advice from industry experts, with the chance to ask questions directly.

Why attend?
By joining this webinar, you will:

  • Gain practical, experience-based insights from notified body experts.
  • Understand how to navigate the certification process with clarity and confidence.
  • Learn how to leverage digital tools for more efficient compliance and documentation.
  • Engage directly with experts in a live Q&A session tailored to participant challenges.
  • Help shape future sessions by contributing to a live poll on the topics you most want covered.

Register now to secure your spot and gain practical strategies for long-term IVDR success.

Agenda

Navigating IVDR compliance: Practical insights and strategies for long-term success.

09:00 - 09:05

Register

Opening and context

  • DNV as a notified body 
  • State of IVDR – timelines etc. 
  • Setting the scene for the session 
09:05 - 09:11

Register

Your biggest challenges solved

Sharing info on the biggest challenges facing people. Based on LinkedIn poll to be shared ahead of the webinar.

09:11 - 09:20

Register

The process explained

  • Quote Request
  • Contract
  • Certification Process 
09:20 - 09:26

Register

Leveraging digital tools & data for IVDR readiness

  • Context and demo.  
  • Using technology for efficient documentation and reporting 
  • Speaker: Expert with digital/data or QA/RA background. 
  • Format: Presentation/demo-style
09:26 - 09:36

Register

Q&A

  • Q&A Speakers: All presenters join. 
  • Format: Moderated Q&A with live audience questions. 
  • Engaging the audience with live examples and questions 
  • Sharing practical advice tailored to participant challenges 
  • Launch Poll of the topics people are interested in so we can take this potentially into a 2nd webinar in the new year, have a better understanding of what people are interested in. 
16:00 - 16:05

Register

Opening and context

  • DNV as a notified body 
  • State of IVDR – timelines etc 
  • Setting the scene for the session 

 

16:05 - 16:11

Register

Your biggest challenges solved

Sharing info on the biggest challenges facing people. Based on LinkedIn poll to be shared ahead of the webinar.

16:11 - 16:20

Register

The process explained

  • Quote Request
  • Contract
  • Certification Process 
16:20 - 16:26

Register

Leveraging digital tools & data for IVDR readiness

  • Context and demo.  
    • Using technology for efficient documentation and reporting 
  • Speaker: Expert with digital/data or QA/RA background. 
  • Format: Presentation/demo-style 
16:26 - 16:36

Register

Q&A

  • Q&A Speakers: All presenters join. 
  • Format: Moderated Q&A with live audience questions. 
  • Engaging the audience with live examples and questions 
  • Sharing practical advice tailored to participant challenges 
  • Launch Poll of the topics people are interested in so we can take this potentially into a 2nd webinar in the new year, have a better understanding of what people are interested in. 

 

Please select the webinar session you would like to attend?

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