AAMI Offers International Standards and Regulation Sessions Online

Contact: Gavin Stern, gstern@aami.org, 1-703-647-2781

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 renowned 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, 2020 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,” said 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 11:00 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 11:00 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 11:00 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.

AAMI (www.aami.org) is a nonprofit organization founded in 1967. It is a diverse community of more than 10,000 healthcare technology professionals united by one important mission—supporting the healthcare community in the development, management, and use of safe and effective health technology. AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for health technology and sterilization professionals.