CMMI Institute

Capability Counts 2019

30 April & 1 May, 2019

Reston, VA

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Speaker Profile

Cisco Vicenty, Program Manager, Case for Quality

FDA

About

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. The Case for Quality is a strategic priority to improve access and outcomes for patients and improve device quality by engaging industry, payers, providers, and patients to focus on the quality and performance of medical devices.
 
Cisco began his career at FDA as a compliance officer in the Cardiac Rhythm and Electrophysiology Branch in the Office of Compliance at CDRH.  Prior to his current role, Cisco was the 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.
 
Cisco Vicenty developed his quality experience in the semiconductor industry as a Quality and Reliability Engineer with the Micro-Electronics Business Unit at IBM responsible for emerging server technology lines, mobile products, network systems, and high-volume gaming technologies.


SPEAKER PRESENTATION

MDDAP: Overview, Progress, and Next Steps

Conference Track: Improving Capability in the Medical Device Industry

The Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) has partnered with the Medical Device Innovation Consortium (MDIC), industry stakeholders, and CMMI Institute to build a pilot program aimed at shifting the industry from a mindset of compliance to one of continuous improvement. Learn how the pilot program works, key accomplishments and lessons learned, and next steps.