From regulatory shifts to AI-driven diagnostics, the AdvaMed 2014 program convenes 2,400+ device and diagnostics leaders across the value chain. Curated sessions, peer-reviewed panels, and accredited continuing education — built for the people who actually build, approve, and commercialize medical technology.
Every session is mapped to one of six thematic tracks designed for cross-functional teams. Mix and match to build the program that matches your role, your company, and the regulatory landscape you're navigating this year.
De novo reclassification, 510(k) reform, EU MDR transition timelines, and the post-pandemic device oversight model.
9 sessionsCMS coverage with evidence development, value-based payment for devices, and winning payer value stories.
8 sessionsMobile medical apps, cybersecurity in connected implants, and the FDA pre-cert pilot's first lessons learned.
7 sessionsAdaptive trial design, real-world evidence for medical devices, and human factors validation in practice.
8 sessionsUDI implementation, sterile barrier validation, contract manufacturer oversight, and post-market supply continuity.
7 sessionsEmerging market entry, hospital purchasing dynamics, and the consolidation of independent reps and distributors.
6 sessionsWe open Monday morning with a candid, on-stage dialogue between the regulators shaping device policy and the CEOs executing against it. No prepared slides — just the questions everyone is asking and the answers no one else will put on the record.
A fireside conversation with the senior leadership of FDA's Center for Devices and Radiological Health, joined by the CEOs of three publicly-traded device companies.
"We have never had a better moment to align what innovators are building with what regulators, payers, and patients actually need. The companies that figure that out first will define the next decade."
Here's a sample of Day One programming. The full agenda includes three days of sessions across six tracks, plus closed-door working groups, roundtables, and the Innovation Showcase on the exhibit floor.
A candid fireside between FDA leadership and three medtech CEOs on regulatory convergence, reimbursement, and global market access.
Reviewing the first wave of de novo decisions post-2012 and what patterns are emerging for novel, low-to-moderate risk devices seeking market entry.
How leading device companies are designing pivotal studies that satisfy both FDA approval and CMS CED requirements — without duplicating cost or timeline.
A live case study of the 2014 pacemaker vulnerability disclosure — what device makers, hospital IT, and regulators learned about coordinated response.
Bayesian methods, sample size re-estimation, and the regulatory guardrails for adaptive designs in 510(k) and PMA submissions.
Hands-on working session for labelers, distributors, and hospital systems preparing for the September 2015 deadline. Bring your GUDID data questions.
AdvaMed 2014 is jointly accredited to issue continuing education credit across the four credential types most device professionals hold. Claim credit for every session you attend — no separate application, no extra fee for attendees.
For physicians attending eligible sessions. Up to 18.5 credits available across the three-day program, claimed through the conference evaluation portal.
Contact hours provided for registered nurses and advanced practice nurses, with reciprocity in California, Florida, and 32 additional state boards.
Maintains Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professionals Society for all eligible plenary and Track A sessions.
Approved by ASQ for recertification credit for Certified Quality Engineers, Auditors, and Biomedical Auditors attending designated Track E sessions.
We deliberately mix formats. A keynote sets the frame, a panel stress-tests it, and a workshop hands you the tools to apply it on Monday morning when you're back at the office.
Cross-cutting conversations with the regulators, payers, and executives setting the industry's direction. 60–75 minutes, designed for the full delegation.
Three or four voices from across the value chain — manufacturer, regulator, payer, provider — debating the same question from genuinely different vantage points.
Small-group, capped at 40 attendees. Bring a laptop and a real problem. Leave with a working artifact — a regulatory submission draft, a CED study framework, a UDI data plan.
De-identified post-mortems of product launches that worked, and ones that didn't. What the company did, what regulators said, and what the actual outcome was eighteen months later.
Registration includes every keynote, every panel, every workshop, and all eligible continuing education credit. Group rates for teams of five or more from the same company.