Recorded April 25, 2024
Ask the Experts Part II:Insights to MDR/IVDR QMS,
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Join us as we continue some important updates on the current state of EUDAMED activity and suggested best practices. In Part II of our three-part series, our guest panelists, Dr. Bassil Akra of AKRA TEAM and Lisa Van Ryn of Greenlight Guru will discuss what to know about QMS and the elements necessary for compliance with MDR/IVDR. Separately, we will review specific device use cases for ‘nonconformity’ and special scenarios with suggested approaches.
For a customized demonstration: MedDevice@ReedTech.com, +1-215-557-3010
Learn more about our panelists below.
Gary Saner is a Sr. Manager of Information Solutions in the Reed Tech Life Sciences group. He is a subject matter expert on Drug Labeling, Medical Device UDI, and other structured content reporting to regulatory agencies and commercial organizations. He has over 40 years of experience in software development, process management, and data administration, with the last 19 years focused on the Life Sciences industry. With a deep understanding of regulations, business requirements, and systems, he has helped shape and implement successful solutions at Reed Tech for data management, validation, processing, and submission of Drug Labeling content, Cosmetic information, and Medical Device UDI data. He serves as chair of the industry’s Structured Product Labeling (SPL) Technical Team.
Dr. Bassil Akra is the CEO and Owner of AKRA TEAM, a globally acting consultancy company. 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.
Lisa Van Ryn helps medical device companies grow and implement state-of-the-art quality management systems. She has 16+ years of experience in Quality Assurance and Manufacturing Operations specializing in audits, management, documentation, regulatory reporting, systems software, engineering, and continuous improvement in the medical device industry.
info@akrateam.com |
support@greenlight.guru |
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Unique Device Identification (UDI)
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