1805 Geary BlvdThu, Nov 26th, 2026 - 6:30PM to 10:00PMThe Fillmore

Where the next generation of devices get built.

Three days of clinical engineering, regulatory strategy, and commercialization for the people designing, testing, and shipping the devices that keep patients alive.

Vital-signs monitor tracing ECG, pulse and respiration waveforms

2,400+

Attendees

80

Sessions

120

Exhibitors

FDA 510(k) & PMA strategyHuman factors & usabilitySoftware as a Medical DeviceReimbursement & market accessSterile design & materialsAI/ML in diagnostics

The Program

Six tracks, one workflow.

From bench prototype to cleared, reimbursed, and shipped — every stage has a room.

01 / Regulatory

Clearance & Compliance

510(k), De Novo, PMA pathways, and the new AI/ML predetermined change control plans.

02 / Engineering

Design & Test

Design controls, verification & validation, risk management under ISO 14971.

03 / Software

SaMD & Connectivity

Cybersecurity, interoperability, and shipping software that regulators trust.

04 / Clinical

Evidence & Trials

Study design, real-world evidence, and building the clinical case for adoption.

05 / Commercial

Access & Reimbursement

CPT coding, payer strategy, and pricing a device the market will actually buy.

06 / Manufacturing

Scale & Quality

QMS, supply chain resilience, and moving from pilot line to full production.

07 / Startups

Founders' Lab

Fundraising, IP strategy, and the first-hire decisions that make or break a medtech.

08 / Frontier

What's Next

Implantables, closed-loop systems, and the diagnostics that don't exist yet.

On Stage

The people shipping it.

Regulators, chief engineers, and founders who've taken devices from concept to clearance.

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Day One

How a day runs.

Keynotes in the morning, breakouts by track after lunch, and clinical demos into the evening.

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Registration

Pick your pass.

All passes include the exhibition floor, session recordings, and the Sept 15 reception.

Single Day

$495

per day

  • One day of your choice
  • All track breakouts
  • Exhibition floor access
  • Session recordings
Most popular

Full Conference

$1,295

per person

  • All three days
  • Every track & workshop
  • Welcome reception
  • Recordings + slide library
  • Attendee networking app

Team (5+)

$995

per person

  • Everything in Full Conference
  • Volume rate for 5+
  • Reserved team seating
  • Dedicated onsite coordinator

Thu, Nov 26th, 2026 - 6:30PM to 10:00PM · The Fillmore · 1805 Geary Blvd

Build the device.

Then meet the room.

2,400 engineers, regulators, and founders gather once a year. Early-bird pricing closes June 30.