USDM can help you implement a GxP-compliant framework for every layer of your tech stack and maintain your validation. Let our team alleviate your compliance headaches and let your team focus on innovating.
USDM and our strategic partners meet your requirements for business optimization, quality, and compliance. Whether you are an emerging biotech, an established medical device manufacturer, or somewhere in between, we have solutions for you.
From webinars to white papers, read or listen to the latest thinking from our life science industry leaders
Digital Transformation is Critical to Business Continuity
He developed the framework and authored key requirements for the U.S. Food and Drug Administration’s (FDA’s) Unique Device Identification (UDI) System.
At USDM, Jay provides business process, technology, and compliance solutions for the regulated life sciences industry, and consults with medical device manufacturers to help them achieve regulatory compliance and a competitive advantage with UDI implementation.
Jay held various positions in his nearly 27 years at the FDA, including working with design control regulations to reduce the chance of human errors with medical devices, patient safety, and adverse event reporting. He also worked in the Office of the Commissioner of the FDA, and the Office of Compliance at the FDA. Just prior to USDM, Jay was the Senior Advisor for Patient Safety in the FDA’s Center for Devices and Radiological Health.
Webinar: UDI Registration in EUDAMED - Why and How to Use It Now
Blog: An Open Letter to Medical Device Regulators
Webinar: Reimagining Medical Device Post-Market Surveillance
Guide: EU MDR Date of Application Readiness
White paper: The Direct Marking of Medical Devices in the U.S. and Europe
Blog: More Medical Device Implications of Brexit
Key differences in the requirements for SFDA UDI and US & EU UDI
Evolving Global UDI Product Data Requirements
Take the first step towards creating more value with USDM today.