How are advancing and emergent technologies changing the delivery of healthcare and what are the implications for medical device standards and regulations?
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For more than three decades, AAMI has hosted the AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation; the premier event for medical device experts who want to be up-to-date on the latest developments, changes, and trends in
health technology standards and regulations. This October, the global medical device standards community will come together in-person for the first time since 2019 for a dynamic and practical review of recent changes to the regulatory landscape and
lessons learned from the pandemic on the global medical device marketplace.
The AAMI/FDA/BSI International Conference will be held on Tuesday and Wednesday, 18-19 October 2022 in Arlington, Virginia.
AAMI will also offer the following half day symposia the day before the main conference, Monday, 17 October 2022:
- In Vitro Diagnostics Symposia (1:30 pm to 5:30 pm). What does the newly implemented European In Vitro Diagnostics Regulation require of IVD manufacturers? What standards are being applied? What is
the FDA doing with IVDs? Join this event to learn about these requirements and discuss the challenges of conducting IVD clinical trials for Europe
- Combination Products Symposia (1:30 pm to 5:30 pm). Managing the manufacture of combination products is complicated by differing regulatory requirements for the drug, device, or biologic components. This session will discuss how quality
systems and risk can be managed for these devices and review how regulators are treating and classifying combination products in different global jurisdictions.
- Managing Standards for Your Organization (1:30 pm to 5:30 pm). Managing information about changing standards and regulatory recognition of those standards is challenging for even the largest medical technology companies. Join this
event to learn about medical device standards, how regulators use them, how to research them and what are best practices for corporate standards management.
Join us 18-19 October 2022 in Arlington, Virginia for what will be an unforgettable convening. Registration for one pre-conference symposium on 17 October 2022 is included in the main conference registration, but
space for the Monday symposia is extremely limited and expected to fill quickly.