15th Annual Medical Device Quality Congress


Sean BoydCAPT Sean Boyd

Deputy Director for Regulatory Affairs, Office of Compliance, CDRH, FDA (invited)

Sean's Bio

Stephan ButtronStephan Buttron

Principal Medical Research Manager of Regulatory Affairs at NAMSA (invited)

Stephan's Bio

Seth CarmodySeth Carmody

Staff Fellow, Office of the Center Director, CDRH, FDA (invited)

Seth's Bio

Lisa CasavantLisa Casavant

Executive Vice President, Regulatory and Quality Solutions LLC (R&Q)

Lisa's Bio

Stephanie ChristopherStephanie Christopher

Program Director, CfQ & PCBR, MDIC (invited)

Stephanie's Bio

Al CrouseAl Crouse

Sr. Quality Director, CVRx Inc.

Al's Bio

Maria FaganMaria Fagan

President and Cofounder, Regulatory and Quality Solutions LLC (R&Q)

Maria's Bio

Connie HoyConnie Hoy

Executive Vice President of RA/QA, Cynosure

Connie's Bio

Anne Le RouzoAnne Le Rouzo

West Coast Regional Director & Certification Project Manager/Lead Auditor, LNE/G-MED North America, Inc. (invited)

Anne's Bio

William MacFarlandWilliam MacFarland

Director, Division of Enforcement, Office of Compliance, CDRH, FDA (invited)

William's Bio

William MaiselWilliam Maisel

Acting Director, Office of Compliance, CDRH, FDA (invited)

William's Bio

Elaine MessaElaine Messa

President of the Medical Device Practice, NSF Health Sciences; former Director of the Los Angeles District, FDA

Elaine's Bio

Steve NiedelmanSteve Niedelman

Lead Quality Systems and Compliance Consultant, King & Spalding LLP; former FDA Deputy Associate Commissioner for Regulatory Operations

Steve's Bio

Dan O’LearyDan O’Leary

President, Ombu Enterprises LLC

Dan's Bio

Gregory Pappas, M.D., Ph.D.Gregory Pappas, M.D., Ph.D.

Associate Director for National Devices Surveillance, Office of Surveillance and Biometrics, CDRH, FDA (invited)

Gregory's Bio

Robert RuffRobert Ruff

Executive Director of Medical Device Education and Training, NSF Health Sciences; former Medical Device Specialist and Senior Investigator at ORA and International Team Lead at CDRH, FDA

Robert's Bio

Carol RyersonCarol Ryerson

Sr. Principal Advisor, Regulator Affairs, RCRI

Carol's Bio

James ShoreJames Shore

President, Quality Lean Solutions

James's Bio

Ibim TariahIbim Tariah

Technical Director, BSI Americas Inc. (invited)

Ibim's Bio

Karl VaheyKarl Vahey

Vice President Manufacturing Quality, Cardinal Health

Karl's Bio

Francisco VicentyFrancisco Vicenty

Program Manager for the Case for Quality, Office of Compliance, CDRH, FDA (invited)

Francisco's Bio