Watch this webinar to learn how, in response to the COVID-19 pandemic, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) collaborated with Siemens Digital Industries Software to explore the application of advanced digital design and manufacturing technologies to improve production agility and resume safe manufacturing operations. This presentation will feature several use cases and emphasize how a digital thread approach has the potential to transform the way manufacturers design and manufacture medical devices, and how they interact with regulatory agencies.
Case for Quality Project Lead
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.
Program Manager, Center for Devices and Radiological Health
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.
Team Lead, Quality and Compliance Staff
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.
Acting Senior Consumer Safety Officer
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.
Senior Director of Medical Device Processes
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.