About
The EU In Vitro Diagnostics Regulation (IVDR) has brought forth a multitude of challenges for manufacturers of IVD devices. With the requirement of assessment by a Notified Body for market access, many manufacturers find themselves navigating unfamiliar territory. Join us for an insightful webinar designed to guide you through the fundamental requirements of the IVDR and help you avoid common pitfalls.

In this session, we will provide:

  • A comprehensive overview of IVDR Clinical Evidence with a focus on scientific validity, state of the art, and clinical performance equipping you with a roadmap to achieve CE certification

  • Best practices for documentation preparation: Gain valuable insights into best practices for preparing technical documentation that meets the stringent requirements of the IVDR

  • In-depth understanding of the intricacies of device registration, ensuring you possess the knowledge to successfully navigate the EUDAMED requirements

    • Our esteemed panel of experts will share their insights, covering best practices for the preparation of technical documentation, current timelines to ensure continued market access, and the specific requirements for device registration in EUDAMED. Drawing from their experience, they will highlight common pitfalls encountered and share valuable lessons learned.
    Don't miss this opportunity to gain clarity and actionable knowledge in the realm of IVDR compliance. Our panel of experts will be available to answer your questions and provide invaluable guidance throughout the webinar.
    Register now to secure your spot!

    Part of the Cracking the Code: Demystifying EU MDR and IVDR Compliance webinar series:

  • Webinar One: Demystifying EU MDR: Navigating Compliance Challenges and Achieving CE Certification

  • Webinar Three: How to pass your Clinical Evaluation Assessment Report (CEAR): Creating a pragmatic systematic literature review process to assure EU MDR approval
    • When
    Wednesday, July 26, 2023 · 10:00 a.m. Eastern Time (US & Canada) (GMT -4:00)
    Agenda
    • Q&A with Panelists
    Presenters
    1689000033-a90eec3b7e676329
    Stefan Burde, PhD
    Director, Global Focus Team IVD at TÜV SÜD
    Stefan Burde, PhD is the Director, Global Focus Team IVD at TÜV SÜD, a leading full-scope Notified Body under the European Medical Device and In Vitro Diagnostic Regulations (EU) 2017/745 and (EU) 2017/746. Stefan holds a PhD in Pathology from the University of Rochester, and has over 13 years of experience in the in vitro diagnostic industry and over 9 years of Notified Body experience as an auditor, technical documentation reviewer, and strategic director. He has spoken extensively at international conferences on topics related to IVDR implementation and compliance.
    1689000117-d846d3f151c1634d
    Gary Saner
    Sr. Manager, Information Solutions, Life Sciences, Reed Tech
    Gary Saner is a subject matter expert on medical device unique device identification and other structured content reporting to regulatory agencies and commercial organizations. He has over 30 years of experience in software development, process management, and data administration with the last 15 years focused on the life sciences industry. He serves as Co-Chair of the industry’s Structured Product Labeling Technical Team and on the Advisory Board of the Medical Devices Group.
    1689000195-0269a891ffe2b687
    Dr. Bassil Akra
    CEO and Owner of AKRA TEAM GmbH
    Dr. Bassil Akra is CEO and Owner of AKRA TEAM GmbH, a globally acting consultancy company from Germany. Dr. Akra and his team at AKRA TEAM are supporting manufacturers achieving compliance and ensuring continuous market access. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has vast experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standards. He spent the last years of his career at TÜV SÜD training and educating various stakeholders on EU Legislations (e.g. MDD/AIMDD, MDR and IVDR), supporting their implementation towards achieving relevant designation ensuring continuity of the healthcare system in the interest of patient populations.
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