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Complimentary Webinar
November 18, 2022 | 11:00 a.m. - 12:00 p.m. ET
Literature Reviews Strategies & Best Practices While Establishing State of the Art for EU MDR Compliance
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Key Learning Objectives:
- The importance of establishing state of the art during the clinical evaluation report.
- Requirements and challenges to build a SOTA framework.
- Literature review strategies and best practices for SOTA search.
- Employing automation and smart workflows to manage large volumes of references and producing compliant literature reviews for CER submissions.
As part of conducting a thorough literature review and clinical evaluation report for EU MDR, it is important to establish a framework that accounts for the generally accepted current knowledge, or the state of the art (SOTA). There is no one size fits all recipe, however. Identifying relevant literature for state of the art is a relatively complex process, and retrieving adequate documentation may be challenging.
How can you develop a methodologically sound framework to include sufficient content to demonstrate state of the art and support claims of device equivalence?
In this webinar roundtable, DistillerSR customers, Shelley Jambresic from Geistlich Pharma and Monique Liston from NuVasive are joined by Dr. Julien Senac from TÜV SÜD and moderated by Dr. Bassil Akra from AKRA Team GmbH. They will reflect on challenges and opportunities for medical device companies establishing state of the art (SOTA) for clinical evaluation reports (CER) as part of their compliance path.
SPEAKERS
Dr. Bassil Akra
Founder & CEO
AKRA Team GmbH
MODERATOR
Dr. Bassil Akra is founder and CEO of AKRA Team GmbH. He spent the last decade as a subject matter expert in the biggest notified body in Europe and represented locally and globally the notified body association in various European roundtables. Dr. Akra played an essential role in the implementation of EU-MDR (MDR 2017/745) and was involved in the drafting of several European guidance documents. He is a regular speaker in the medical devices industry and a recognized authority in EU-MDR compliance.
Shelley Jambresic
Sr. Clinical Evaluation Manager
Geistlich Pharma AG
Dr. Julien Senac
Global Director of the IVD
Focus Team, TÜV SÜD
Monique Liston
Senior Medical Writer
NuVasive Inc.
David Kovac
Account Executive
DistillerSR
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