FDA/CDRH officials present first-hand advice

Daniel Walter

Case for Quality Project Lead, US Food and Drug Administration

Daniel Walter is a member of the compliance and quality staff in the FDA’s Office of Product Evaluation and Quality’s Immediate Office of the Center for Devices and Radiological Health (CDRH). He is currently the Project Lead for Case for Quality, which is an ongoing strategic priority for CDRH, aimed at improving patient access and outcomes, and medical device quality. His background includes being a compliance officer in the CDRH’s Office of Compliance’s Vascular and Circulatory Support Branch; chief of the Foreign Enforcement Branch in the Division of International Compliance Operations overseeing medical device manufacturers; and additional regulatory and industry roles.

Francisco Vicenty

Program Manager, Center for Devices and Radiological Health, US Food and Drug Administration

Francisco (Cisco) Vicenty is currently the Program Manager for the Case for Quality (CfQ) within the Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA. This follows roles as branch chief of the Respiratory, E/N/T, General Hospital, and Ophthalmic Devices Branch in the Division of Manufacturing and Quality within the Office of Compliance; as compliance officer in the Cardiac Rhythm and Electrophysiology Branch in CDRH’s Office of Compliance at CDRH; and as a quality and reliability Engineer with IBM’s Micro-Electronics business unit.

Bleta Vuniqi

Team Lead, Quality and Compliance Staff, US Food and Drug Administration

Bleta Vuniqi is a Team Lead within the Quality and Compliance Staff in OPEQ/IO. Bleta has been with the FDA since 2010. Previously, Bleta was the Quality System Specialist within DMQ/OC, and Senior Program Expert in OPEQ/ORP/D1 focusing on PMA policy and process improvement. She previously held a biomedical engineering role within the Respiratory, ENT, General Hospital and Ophthalmic Device Branch in OC where she conducted post market activities regarding these devices and provided regulatory advice in making decisions and resolving regulatory conflicts. Before joining CDRH Bleta was an FDA investigator in ORA responsible for conducting medical device inspections and investigations. She graduated from Wayne State University with a Masters in Biomedical Engineering and Bachelors in Chemistry.

Christopher Brown

Acting Senior Consumer Safety Officer, US Food and Drug Administration

Christopher holds a B.S., and Graduate Certificate in Mechanical Engineering from the University of Maryland, and M.S in Technology Management from University of Maryland University College. He has the following Certifications: Medical Technology (MT), ASQ Certified Manager of Quality/Organizational Excellence, ASQ Quality Auditor, Six Sigma Black Belt, and Capability Maturity Model Integration (CMMI). He is a licensed Professional Engineer and a US Air Force veteran.

Larry Sampson

Senior Director of Medical Device Processes, Siemens Digital Industries Software

With 20-years of operational experience in Medical Device, Larry Sampson knows firsthand how to balance device development agility and regulatory considerations. As a Sr. Director of Medical Device Processes at Siemens, Larry spends his days educating medical device manufacturers on best practices in all aspects of their product lifecycles. Outside the 9-5, Larry enjoys the great outdoors of Colorado with his family.