Real-World Lessons from Companies Navigating the Challenges in Achieving EU-MDR Certification

An FDAnews FREE Webinar • Sponsored by ComplianceQuest
Thursday, July 8, 2021 • 1:30 PM - 2:30 PM EDT

Are you ready for the EU-MDR? The new regulations took effect on May 26, 2021 and ensuring your device can make it successfully to market in the EU requires certification under them. Planning for these adjustments takes concerted effort, close collaboration and intentional organizational adaptations.

But does your team know all the bumps, hurdles, and secrets to get you through? For example, your NB may be accredited but do they have “qualified” reviewers for your clinical, quality and technical files? You better check!

Your company may believe your clinical study documentation is adequate but due to the increased clinical documentation requirements in the EU-MDR it may not. Are you ready for the additional work? You better check!

Your technical documentation review is scheduled for next month and your quality system audit review is 2 months from now. There could be Technical documentation delays. Certification must be given within 6 months of stage 2 Quality System audit, or the company must start over resulting in more cost and delays. So, who is talking to who? Do you have the communication framework across, up, down, inside, and external? Are your timelines aligned and coordinated? You better check!

Your stakeholders expected at least several months of product revenue from the EU in 2021, but the CE Mark/QMS certification process is taking much longer than you ever expected. What are you going to tell them? Do you have your plan in place to deal with these delays or any negative effects? What are your course corrections? You better check!

Join us in this webinar, sponsored by ComplianceQuest, to get real-world insight into many of the above issues and even more. You’ll gain a detailed understanding of some of the hurdles to overcome as you face the EU-MDR certification process. Hear recommendations on how to best review your company’s quality management systems and come up with a timeline for any necessary adjustments. You’ll be able to prepare yourself and your team for these inevitable hurdles and successfully navigate the process.

Key takeaways:

  • What to know about expected challenges during the transition
  • Where to focus and prioritize in the EU-MDR certification process
  • Coordinating and planning around your Notified Body
  • Balancing the Technical file and QMS audit review
  • Creating product technical documentation and clinical study documentation for certification
  • How to incorporate the new EU-MDR framework into your company’s quality management system
  • Getting ready for the EUDAMED database
  • Coordinating and planning around EU-MDR expectations
  • Minimizing the impact of EU-MDR changes on your company operations

Don’t miss this chance to gain expert insight into real world experiences that you can leverage for your successful certification path.

Join us by registering now.

Who Will Benefit

  • Medical device companies
  • Quality assurance teams
  • Engineering professionals
  • Quality compliance staff
  • Regulatory compliance staff
  • QA and RA managers and directors
  • Supply chain management teams
  • CEOs
  • COOs
  • Operations leadership
  • Regulatory affairs leadership
  • European market experts
  • Economic Operators

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Meet Your Presenter

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Linda L. S. Lovett

CEO
Lovett Consulting

Linda L. S. Lovett is the CEO of Lovett Consulting and has more than 30 years of experience in quality assurance, regulatory compliance, audits and regulatory remediation. She specializes in strategic and tactical leadership in the medical device and in vitro diagnostic industries. Lovett has held leadership positions at companies including Maya Medical, Abbott Laboratories, Kyphon and Medtronic. She has helped organizations with successful integration and alignment of business, quality assurance and regulatory compliance goals for US and international environments.