AdvaMed® Medical Device Cybersecurity Foundational Principles
Medical device manufacturers take seriously the need to continuously assess the security of their devices.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
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.
The Machines Are Coming (And Lawsuits Too): Mitigating Risks of Device Design, Manufacture, and Sale Amidst the AI Revolution
Explore the latest regulatory trends impacting AI and machine learning-enabled medtech devices in this free webinar.
Evolution of FDA Regulatory Framework for Clinical Decision Support Software
Explore the various factors and considerations at play in determining whether a CDS product is likely to be actively regulated.
16th Annual King & Spalding Medical Device Summit
Register for the 16th Annual King & Spalding Medical Device Summit in Chicago!