We are excited to host a panel discussion during next week's virtual RAPS Euro Convergence 2021! Join our expert panel for our session on IVDR Implementation Best Practices and Challenges.

See the schedule here and find more details on our session below.

When

Tuesday, 11 May 2021 from 12:00 – 13:00 CEST

Where

RAPS Euro Convergence 2021 is virtual this year, so as long as you are registered for the conference you will be able to attend our session online.

What

May 26, 2022 is still the IVDR date of application, and it is speeding towards us! With limited time and resources, where should you focus to increase your odds of a successful certification audit? This panel discussion is the premier opportunity to learn from the experiences of seasoned experts – included a notified body’s perspective – as they share their IVDR implementation successes and failures so far… along with answers to your questions.

While there have been and will continue to be plenty of implementation challenges, our esteemed panel has worked through comprehensive strategies and solutions, and is prepared to share their learnings and tips for success.

We will start the discussion by addressing the following questions we have received:

  • Notified Bodies - Learning how to work with them under tight constrictions of notified body availability and DOA approaching fast.
  • Quality Management System - Developing a QMS that is robust enough to pass an audit and provide value-add to the business.
  • Risk management - How to approach remediation of this known area of weakness for IVD companies.
  • Post-Market Surveillance - PEP, PER, PMPF Plan/Report, and PSUR - What is within each and how do they interact?
  • Economic Operators - Setting up EO agreements, which starts with sorting out the virtual manufacturing and distribution relationships that can be very convoluted in the IVD world.
  • When to say DONE - Aligning on what is ‘good enough’ for your company, when the regulation is so new and the notified bodies do not have or cannot provide the answers.

You will walk away from this session with actionable takeaways to apply to your own organisation’s IVDR implementation plan. Get the most out of the session by bringing your own questions for our experts to answer live!

Learning Objectives:

  • Upon completion, participants will be able to describe multiple best practices and lessons learned related to common IVDR implementation challenges, making an immediate impact by applying to your IVDR implementation strategy, processes, and documentation.
  • Upon completion, participants will be able to prepare for and respond to notified body audits, equipped with knowledge of what typical notified body findings have been so far and how to avoid them.

Who

The session moderator, Lisa Casavant, Executive VP of RQM+, will start the discussion with questions we have received so far on IVDR topics and answer your questions as they come in. Our expert panel includes:

  • Simon Richards – VP of Regulatory Affairs, Abbott Rapid Diagnostics
  • Laura Tracy – Senior Manager of Global Regulatory Affairs, Leica Biosystems
  • Dr. Andreas F. Stange – Vice President MHS Global IVD, TÜV SÜD
  • Dr. Amie Smirthwaite – Head of Clinical Regulatory Affairs, RQM+

 

How can RQM+ help?

RQM+ delivers business-balanced strategy and tactical execution for transitioning companies of all sizes to the EU In Vitro Diagnostic Regulation (IVDR). Explore our variety of IVDR resources, from our EU IVDR Planning and Execution Solutions to IVDR education resources. Our expert team is ready to support you throughout your IVDR implementation journey. Contact us today to learn more.

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

Book a Consultation

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