Artificial Intelligence in Medtech
Artificial intelligence has been in the spotlight recently, but it is not a new concept to the Food and Drug Administration (FDA) or the medtech industry. AI advancements in the…
Regulatory Affairs
Learn more about our Regulatory Affairs work.
Artificial Intelligence in Medical Technology Myths and Facts
Outlining the facts and dispelling myths will inform policymaking to avoid overlap with current regulations and preserve the broad capacity of innovation to help patients.
Principles for Artificial Intelligence in Medical Technology
This document provides the medical device industry’s foundational principles for artificial intelligence in medical technology. These principles will guide further innovations, policymaking, and regulations in AI-enabled medical technology.
AdvaMed Medical Device Cybersecurity Foundational Principles
Medical device manufacturers take seriously the need to continuously assess the security of their devices.
AdvaMed Urges FTC to Not Implement Right to Repair Policies for Medical Devices
Advamed, the Medtech Association, submitted comments to the Federal Trade Commission in response to a request for public comment on rulemaking regarding “right to repair” policies. AdvaMed and AdvaMed’s Medical…
AdvaMed 2024 State Policy Briefing: AI in Healthcare
AdvaMed experts gave a presentation on how FDA regulates AI/ML in medical devices and how Medicare reimbursement policy is impacted by digital health technologies.
Managing Requirements – A Systems Approach to Medical Device Requirements for efficient and compliant design and development
Sunrise Labs outlines a systems approach to medical device requirements for efficient design and development..
FDA/AdvaMed Medical Device Statistical Issues (MDSI) Conference
Join leading authorities from FDA, academia and industry to address the latest statistical trends and issues facing medtech organizations.
Innovation and Safety: The Unique Challenges of Complex Safety-Critical Medical Device
Join Sunrise Labs and AdvaMed for this insightful webinar on medical product development best practices.
Medical Device Submissions Workshops
Our in-depth device submissions workshops will provide real-world case studies, tips and best practices directly from FDA and industry experts.