January 18, 2018
Amber Logan, firstname.lastname@example.org 703-253-8262
AAMI Conference Promotes Medical Device Industry Success in a Changing Regulatory World
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) this spring.
The International Conference on Medical Device Standards and Regulations, which will be held March 22–23 at the Crystal City Marriott in Arlington, VA, will bring together regulators and standards leaders from around the world to report on some of the biggest 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.”
The first part of the conference will focus on FDA compliance and will explore:
- Recent legislative 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
- Accreditation scheme for conformity assessment
- The agency’s digital health initiatives
The second part of the conference will provide an international update, focusing on:
- Medical device quality systems, today and tomorrow
- Medical device single audit program
- Revision of ISO 14971, Medical devices – Application of risk management to medical devices
- The new European Medical Device Regulations
- Postmarket surveillance
Other topics to be discussed include the development of national and international cybersecurity standards, an overview of current and planned guidance for additive manufacturing, and ongoing efforts to explore 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, so early registration is encouraged. For more information, including the full conference agenda, visit www.aami.org/isc.
AAMI (www.aami.org) is a nonprofit organization founded in 1967. It is a diverse community of approximately 7,000 healthcare technology professionals united by one important mission—supporting the healthcare community in the development, management, and use of safe and effective healthcare technology.