Ask the Experts: Critical Steps in Implementing Your EU MDR/IVDR Plan
October 25, 2023, 10:00 AM EST
Register to the Webinar Ask the Experts: Critical Steps in Implementing Your EU MDR/IVDR Plan
Ask the Experts:
Critical Steps in Implementing Your EU MDR/IVDR Plan
This information-packed webinar teaches the critical steps to implement your EU MDR/IVDR plan successfully. The MDR/IVDR Dates of Application have passed, and as a medical device manufacturer, you should be briskly walking down your path toward compliance.
This webinar will be invaluable if you haven’t started your journey or if you have started and need to check your compass to make sure you are on course. Rosholt Consulting and Reed Tech experts will outline a plan and provide best practices for medical device manufacturers to meet the ever-changing requirements. After the product technical documentation is in place, we will emphasize the internal infrastructure and EUDAMED reporting challenges.
Key Takeaways:
Learn the 12 Critical Steps in Planning/Executing your MDR/IVDR Strategy
Ensure your Gap Analysis and Project Plan are Complete and Comprehensive
Learn About the EUDAMED Actor and UDI/Device Voluntary Registration
Identify the MDR/IVDR Label Requirements
Learn Best Practices and Errors to Avoid
Understand Compliance Timing Deadlines
Who does this apply to:
Global Strategy Business Managers
Regulatory Affairs/Operation Leaders
Product Managers and Business Analysts
Manufacturing, Operations, and Supply Chain Leaders
Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech
Tommy Rosholt
LinkedIn
Tommy Rosholt is a Medical Device Senior Consultant, Project Manager, and Owner at Rosholt Consulting. He is a subject matter expert in UDI Analysis, strategy, and implementation, specializing in labeling and End2Dnd processes, regulatory master data, and traceability standards implementation. He employs a holistic approach to UDI implementation, focusing on streamlining regulatory complexity into compliant and operational solutions.
Gary Saner
LinkedIn
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.
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.
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.
