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WEBINAR RECORDING

Ask the Experts:
Insights to MDR/IVDR QMS,
Nonconformities and Special Scenarios 

(May-26 & Sep-26 deadlines 2024 thru 2027)

Recorded April 25, 2024

Register to view the webinar 

Ask the Experts:
Insights to MDR/IVDR QMS,
Nonconformities and Special Scenarios 

Ask the Experts Part II:

Insights to MDR/IVDR QMS,
Nonconformities and Special Scenarios 
(May-26 & Sep-26 deadlines 2024 thru 2027)

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.   

Key Takeaways: 

  • Get an update on QMS best practices for compliance with MDR/IVDR
  • Key takeaways for special scenarios
  • Best practices to prepare for compliance timelines for MDR/IVDR​ 

Who does this apply to:

  • Global Strategy Business Managers
  • Regulatory Affairs/Operation Leaders
  • Product Managers and Business Analysts
  • Manufacturing, Operations, and Supply Chain Leaders
  • Quality Leaders
  • IT Support

For a customized demonstration: MedDevice@ReedTech.com, +1-215-557-3010

Learn more about our panelists below.


Panelists:

  • Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech
  • Dr. Bassil Akra, CEO and Owner, AKRA TEAM 
  • Lisa Van Ryn, Medical Device Guru, Greenlight Guru
RT - LS - 20210713 - Headshot - Gary Saner Reed Tech Color GreenBG 768x831 - IMG
Gary Saner
LinkedIn

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
Dr. Bassil Akra
LinkedIn

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
Lisa Van Ryn
LinkedIn

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.

Learn more about our panelists


LexisNexis Reed Tech brings clarity to innovation for businesses worldwide. We enable innovators to accomplish more by helping them make informed decisions, be more productive, comply with regulations, and ultimately achieve a competitive advantage for their business. Our Reed Tech suite of SingleSource™ for Medical Devices, SingleSource™ for Drug Products, and Navigator™ for Drug Labels enables life sciences companies to create product data management strategies and meet compliance deadlines on time. We are proud to directly support and serve these innovators in their endeavors to better humankind.

For more information, please visit ReedTech.com.

Life Sciences Solutions Driven by Accuracy and Insight
Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry's data. Our offerings smooth the collection, transformation, submission, and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles.