To help clarify recent and upcoming changes to U.S. and international standards and regulations for medical devices and other healthcare technologies, AAMI is hosting a two-day conference in collaboration with BSI and the Food and Drug Administration (FDA).
The International Conference on Medical Device Standards and Regulations, which will be held March 22-23 at the Crystal City Marriott in Arlington, Virginia, will bring together regulators and standards leaders from around the world to report on major upcoming regulatory shifts and discuss how medical device manufacturers can prepare for these changes. Understanding the evolving landscape is crucial for device manufacturers who want to enjoy continued compliance and global market access.
“The healthcare technology industry is facing a number of significant regulatory shifts in many parts of the world, and there are a number of areas where we anticipate international standards or their implementation to change. This includes the areas of risk management, quality systems and postmarket surveillance,” said Joe Lewelling, vice president of emerging technologies and health IT standards at AAMI. “This conference will address the ‘current state’ and recent and imminent changes to standards and regulations, as well as preview additional changes that may be on the horizon.”
Topics under discussion will include:
• Recent regulatory changes, including the 21st Century Cures Act and the FDA Reauthorization Act of 2017
• Restructuring of the FDA’s Center for Devices and Radiological Health to incorporate a total product life cycle model
• Medical device single audit program
• New European Medical Device Regulations
• Development of national and international cybersecurity standards
• Current and planned guidance for additive manufacturing
• Educational, regulatory, and standards needs related to artificial intelligence and medical algorithms
“This is the premiere event to get information and discuss the emerging issues in standards and regulations, and a unique opportunity to network with regulators, notified bodies, and industry representatives involved in preparing these standards,” said Eamonn Hoxey, an international consultant for quality and regulatory compliance matters who will be presenting at the event.
Seating is limited and AAMI encourages early registration.
For more information, including the full conference agenda, visit www.aami.org/isc.
© 2018, TechNation Magazine. Site designed by MD Publishing, Inc.