Ask the Experts:
What should I know about the EU Legacy Medical Device Amendment?
In recent news, the European Commission enacted an extension to the transition deadline for Legacy Medical Devices to be placed on the EU market. This extension impacted multiple timelines, as well as specific requirements along the EUDAMED roadmap.
In this webinar, experts Ronald Boumans and Gary Saner will answer questions about the reasoning behind this decision and how it affects medical device manufacturers.
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.
Reed Tech is the provider of best-in-class information-based solutions and services to meet the needs of the life sciences industry, government agencies, and the intellectual property market. Our customers are located throughout the world and include a wide range of medical device manufacturers and pharmaceutical companies, the U.S. government, numerous Patent Authorities, and IP-driven companies and law firms. The corporate mission is to advance humanity by delivering better outcomes to the innovation community. Reed Tech is a LexisNexis company.
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.
Boumans Regulatory Consulting offers your team quick access to an expert that can help with global regulatory compliance. In addition, Boumans Regulatory Consulting can execute the role of the PRRC or act as a back-up PRRC. Boumans can also support you in Borderline and classification support, notified body search and selection, and mergers & acquisitions support.