Recorded live at MedTech Innovation & Validation University
Validate Adaptive AI Algorithms in SaMD and Smart Devices
What it takes to validate an algorithm that keeps learning after release. How to write a change plan a reviewer will accept, what evidence holds when the model in the field is no longer the model you tested, and where software quality has to own the monitoring rather than the release.
Abhinavdutt Singh
Staff Software Quality Engineer, iRhythm Technologies
What you'll take away
- How to validate an algorithm whose performance changes after it ships
- Writing a predetermined change control plan a reviewer will accept
- Post-market monitoring that produces evidence, not just dashboards
- Where software quality owns the risk once the device is adaptive
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Validate Adaptive AI Algorithms in SaMD and Smart Devices
Sessions like this one are what MedTech Innovation & Validation University is built on. Keep scrolling for 35+ more, live in Philadelphia on October 7 & 8, 2026.
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MedTech Innovation & Validation University
October 7 & 8, 2026 · Philadelphia, Pennsylvania · In person or virtual
Co-located with GMP University
October 7 and 8, 2026 · Philadelphia, PA
Where the rest of the sessions are.
Two days, thirty-four sessions across the MedTech and GMP agendas, and a faculty of practitioners presenting the programs they run: AI in the QMS, computerized system audits, QMSR, cyber submissions, Annex 1 control strategies, and the inspection questions nobody has clean answers to yet. Abhinavdutt Singh returns this year with two sessions on regulatory pathways and postmarket signals.FDA pathways
FDA Pathways for AI-Embedded Devices in 2026: 510(k), De Novo, PMA — and When a PCCP Actually Helps You
Comparing 510(k), De Novo, PMA, and PCCP strategies for AI-enabled devices in 2026.
Abhinavdutt SinghStaff Software Quality Engineer, iRhythm Technologies
Postmarket surveillance
Postmarket Surveillance Signals: What Should Trigger a Field Action and What Shouldn't
What should trigger a field action and what shouldn't — signals, escalation, and defending 'no action.'
Abhinavdutt SinghStaff Software Quality Engineer, iRhythm Technologies
Audit insight
How to Survive an Audit of Your Validated Computerized Systems
Practical lessons from real audits of validated systems, what inspectors look for, and how to stay ready.
Raul SotoMedTech Senior Manager, Johnson & Johnson
AI in medical devices
The State of AI in Medical Devices: Lessons learned, hard truths, and the path forward
Tracing AI's journey in device development — from early algorithm-driven diagnostics to today's adaptive systems — and the hard lessons on validation, trust, and patient impact that will define the next wave.
Xenophon PapademetrisProfessor of Biomedical Informatics & Data Science, Yale School of Medicine
Annex 1 in practice
Annex 1 in the Real World: Why CCS Documents Look Great on Paper and Fall Apart Under Inspection
Where control strategy documents come apart once inspectors want to see them lived on the floor.
Jim PolarineSenior Technical Service Manager, STERIS Corporation
Change control
Inspection-Proof Change Control: Why Good Changes Still Get 483s
Common change-control failure modes and what 'risk-based' really means to a reviewer.
Cindy DuhiggSenior Principal, Global Manufacturing Science & Technology Engineering, Alcon
“I left with a change-control approach my inspectors accepted.”
MedTech Innovation & Validation University attendee
Speaking from inside the regulated world
Who is on the faculty.
Case studies from the quality, validation, and engineering leaders accountable when a device or a process has to hold up under inspection.
Johnson & Johnson
Cencora
STERIS
Alcon
Organon
Getinge
Yale School of Medicine
QualityHub
PQE Group
The Silverman Group
Genari AI
Compliance Group
KNEAT
VTI Life Sciences
See the rest of the sessions in Philadelphia.
October 7 and 8, at the Wyndham Philadelphia Historic District. Co-located with GMP University, so one registration covers both agendas.
