AAMI News January 2018
Conference Promotes Compliance 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 developments in this arena and discuss how medical device manufacturers can prepare to ensure continued global market access and regulatory compliance.
“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.”
During the first part of the conference, speakers from the FDA’s Center for Devices and Radiological Health (CDRH) will address recent legislative changes, such as the 21st Century Cures Act and the FDA Reauthorization Act of 2017, as well as discuss FDA guidance related to clinical decision support software and digital health products, including the new software precertification program. The agency also will preview the reorganization of CDRH, which will better align the center to a total product life cycle model.
International topics will include:
- The E.U. Medical Device Regulations, including discussions on conformity assessment and in vitro diagnostics
- The implementation of ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes (See related article)
- The Medical Device Single Audit Program
- The revision of ISO 14971, Medical devices—Application of risk management to medical devices
- Postmarket surveillance
Seating is limited, so early registration is encouraged. For more information, please visit www.aami.org/isc.