The world of health technology standards and regulations is changing faster than ever. That’s why, for the first time, AAMI is offering key sessions from its International Conference on Medical Device Standards and Regulation in an online format. The first of the ISC Online Sessions begin the week of June 8, with a focus on quality management systems, risk management, and postmarket surveillance.
“The International Standards Conference is an essential venue for bringing together leading experts from the medical device industry, regulators, and standards professionals. With ISC Online Sessions, we’re responding to the health technology and regulatory communities’ need for insight about the changing regulatory landscape, and have pivoted to deliver content virtually in recognition of that need being ongoing—especially throughout new challenges brought about by the pandemic,” says Amanda Benedict, acting vice president of standards at AAMI.
The sessions beginning the week of June 8 are:
- The Future of Quality Management Systems (June 8 from 11 a.m. to 12:30 p.m. ET). Explores emerging trends in the European Union and within the U.S. FDA to transition to a new edition of the international quality management systems (QMS) standard, ISO 13485.
- The Future of Risk Management for Medical Technology (June 10 from 11 a.m. to 12:30 p.m. ET). Provides an overview of the new risk management standards ISO 14971 and ISO 24917 and discusses challenges in applying risk management in special technologies (e.g., IVDs, artificial intelligence, and combination products).
- Postmarket Surveillance (June 12 from 11 a.m. to 12:30 p.m. ET). Industry experts will review the new ISO technical report on postmarket surveillance, ISO TR20416, and the postmarket surveillance requirements in the EU Medical Device Directives.
Attendees can register for individual sessions or all three. Registration is $65 per session for AAMI members and $80 per session for nonmembers. Registration includes a video recording for later viewing. For more information about ISC Online Sessions and to register, visit www.aami.org/ISC-Online.
This opens an opportunity for BMETs and CEs to become more involved in standards activities. Until now, hospitals were understandably unwilling to pay for the costs of travel associated with active involvement in an international standards activity. Perhaps now some of the reluctance will disappear.
The more provider voices in these activities, the better.