Medical Device / UDI / EU MDR / EUDAMED
Jay Crowley
VP of Medical Device Solutions and Services
Jay Crowley helps medical device manufacturers translate changing global regulatory expectations into practical business process, technology, and compliance programs. He developed the framework and authored key requirements for the U.S. FDA Unique Device Identification system, spent 26 years at FDA, and is globally recognized for his work in UDI, medical device data, patient safety, design controls, adverse event reporting, EU MDR, IVDR, and EUDAMED readiness.
FDA UDI architect
Developed the framework and authored key requirements for the U.S. FDA Unique Device Identification system.
Medical device depth
Brings 26 years at FDA across device compliance, design controls, patient safety, adverse event reporting, and CDRH leadership.
Global readiness
Guides manufacturers through UDI, EUDAMED, EU MDR, IVDR, data governance, and medical device compliance execution.
Jay Crowley's Credentials
Jay helps device manufacturers turn UDI and global regulatory change into executable programs, not spreadsheet archaeology.
His work connects regulatory interpretation, product data, labeling, quality systems, technology, and submission workflows so medical device companies can manage UDI and market-access obligations with more control.
Proof points
26 years at FDA, including work in the Office of the Commissioner, Office of Compliance, and Center for Devices and Radiological Health
Developed the framework and authored key requirements for FDA’s Unique Device Identification system
Former Senior Advisor for Patient Safety in FDA’s Center for Devices and Radiological Health
USDM leadership for UDI, EU MDR, IVDR, EUDAMED, and global medical device regulatory readiness programs
Primary role
Medical device solutions and services
Helps device manufacturers plan and execute regulatory, data, process, and technology programs for UDI and global market readiness.
Where he helps
UDI, EUDAMED, and QMSR readiness
Supports UDI strategy, GUDID and EUDAMED data, EU MDR and IVDR readiness, QMSR implications, and inspection-ready medical device governance.
How Jay helps clients solve it
Jay Crowley's Resources
Resources that prove the expertise.
A focused shelf of content tied to Jay's work across medical device regulatory strategy, UDI, EU MDR, IVDR, EUDAMED, and patient safety leader.
April 22, 2026
EU MDR/IVDR EUDAMED Readiness: What Medical Device Manufacturers Need to Do Now
A practical readiness guide for medical device manufacturers preparing device data, registration processes, governance, and EUDAMED execution.
February 5, 2026
UDI and FDA’s New QMSR Inspection Process
How FDA’s QMSR and updated inspection program put UDI, ISO 13485 alignment, GUDID accuracy, and inspection readiness together.
August 11, 2025
UDI Compliance and the Future of Medical Device Data
A medical device data perspective on EUDAMED, UDI mistakes, data integrity, market access, and compliance readiness.
March 1, 2024
A Few Surprises in FDA's Quality Management System Regulation
A Jay Crowley perspective on QMSR, ISO 13485, traceability, recall scope, UDI records, and risk-based validation.
September 1, 2022
UDI Beyond Borders
A global UDI webinar covering policy, data quality, medical device identification, and international regulatory requirements.
April 18, 2021
The Direct Marking of Medical Devices in the U.S. and Europe
UDI direct marking guidance for reusable devices, exception rationale, marking technologies, and inspection-ready traceability.
Contact Jay Crowley
Start a conversation about UDI, EUDAMED, or medical device compliance before deadlines start doing the project management.
Use the form to route a conversation about UDI strategy, EUDAMED readiness, EU MDR, IVDR, GUDID, QMSR, medical device data, labeling, quality systems, or global regulatory execution.