AAMI News February 2018

Changing Quality Requirements Set Stage for International Standards Conference

Just because a quality system is compliant with applicable standards and regulations today doesn’t mean it will be tomorrow. That’s because a lot of changes are on their way in a number of different countries, according to Eamonn Hoxey, an international quality and regulatory compliance consultant.

To help clarify these changes to U.S. and international standards and regulations for medical devices, AAMI is hosting a two-day conference, in collaboration with BSI and the Food and Drug Administration (FDA), March 22–23 at the Crystal Gateway Marriott in Arlington, VA.

“We are just coming into the final year of the transition to ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes, and new certificates will not be issued to the old edition of the standard after February of this year,” said Hoxey, who is chair-elect of the AAMI Board of Directors. “We also are just starting the transition to the European Medical Devices and IVD Regulations, and these have particular requirements for quality systems that need to be planned and implemented.”

Additionally, Canada is transitioning from its Canadian Medical Devices Conformity Assessment System to using the Medical Device Single Audit Program, and the FDA is working with manufacturers on its Case for Quality initiative to improve product and manufacturing quality, Hoxey noted.

“This is a lot of change to accommodate in a short period, and time is ticking on many of these transitions,” he added. “Keeping abreast of the changes and planning implementation in an orderly fashion without redundancy is a challenge.”

Next month’s International Conference on Medical Device Standards and Regulations will bring together global regulators and standards leaders, such as Hoxey, to report on some of the biggest developments and discuss how medical device manufacturers can prepare to ensure continued global market access and regulatory compliance.

“This is the premiere event to discuss emerging issues in standards and regulations, and a unique opportunity to network with regulators, notified bodies, and industry representatives involved in preparing these standards,” Hoxey said.

Seating is limited, so early registration is encouraged. For more information, including the full agenda, visit www.aami.org/isc.