15th Annual Medical Device Quality Congress

Speakers

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

 

 

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