Legacy identity systems can’t keep up with modern healthcare. Join HID Global and USDM’s Jay Crowley—architect of the FDA’s UDI system—for a strategic look at how next-generation device identity is reshaping compliance, security, and operational performance. Discover how to design devices that are not only compliant, but intelligent, efficient, and built for the future of connected healthcare. ✅ AI-powered authentication to enhance trust and efficiency ✅ Security-first architecture tailored to regulated environments ✅ Proven strategies to embed identity into your IT and compliance roadmap At USDM Life Sciences, we partner with life sciences organizations to evolve regulated operations using intelligent, compliant technologies. This webinar is essential for IT and Quality leaders seeking actionable insights to align R&D, regulatory, and operational priorities—and accelerate device readiness for market. 📅 Register now: https://lnkd.in/g8ruWueY
USDM Life Sciences
IT Services and IT Consulting
Santa Barbara, CA 16,282 followers
Technology optimized. Compliance simplified.
About us
How fast can a life sciences organization move with innovative information technology at the core of every action? What if routine, regulated tasks across departments and continents were automated? What if business insights soared from carefully crafted algorithms that fueled confident business decisions? What if the scientific discovery was made safer and faster without the fear of an imminent FDA audit? Life sciences companies are challenged because the very core of their work is about human existence – improving and extending life itself. Regulators have massive civic responsibilities, but the government regulations slow the advancement of life sciences and medicine. At USDM Life Sciences, our purpose is to bring clarity and action at the interplay of technology and regulations to help biotech, pharma, and medical device companies deliver trailblazing outcomes. We help our customers utilize cutting-edge technology to increase their speed to market while ensuring continuous compliance and patient safety. Google, Microsoft, Amazon, Oracle, and every other top technology company trust USDM to ensure their technology is adopted effectively, powerfully, and in compliance. Thousands of life science companies choose USDM to bring the future of work into the present. We make digital transformation in highly regulated areas possible, even simple, and everyone wins – especially the patient. Technology optimized. Compliance simplified.
- Website
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http://usdm.com/
External link for USDM Life Sciences
- Industry
- IT Services and IT Consulting
- Company size
- 201-500 employees
- Headquarters
- Santa Barbara, CA
- Type
- Privately Held
- Founded
- 1999
- Specialties
- Risk Management, Data Integrity & Compliance, Technological Innovation, Regulated System Implementation & Validation, Business Process Optimization, Regulatory Compliance, Digital Transformation, and Infrastructure Qualification
Products
![Click here to view USDM Cloud Assurance]()
USDM Cloud Assurance
SaaS Management Software
USDM Cloud Assurance is a managed subscription service delivering end-to-end GxP compliance from your initial system implementation and validation through ongoing validation release management -- for your SaaS, PaaS and IaaS technologies. Benefits • Rapid implementation, validation, and maintenance of your tech stack • Includes vendor audit and IS Health Check • Faster implementation and adoption to maximize ROI • Scalable solutions that evolve with your cloud roadmap • Extensive digital transformation services including people and process changes • Adapted for traditional CSV or the FDA’s new CSA approach • Trusted by more than 200 life sciences companies Shrinking IT budgets and growing business demands mean that you need a cost-effective, time-saving, managed service to achieve your business objectives. USDM Cloud Assurance combines cost savings and risk reduction to manage your technology and compliance processes so you can focus on other priorities.
Locations
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Primary
Get directions
535 Chapala St
Santa Barbara, CA 93101, US
Employees at USDM Life Sciences
Updates
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USDM Life Sciences reposted this
🗽 USDM is heading to the ServiceNow World Forum in NYC this week! We’re excited to connect with our Life Sciences customers and partners to explore how integrating AI into digital workflows is optimizing efficiencies and driving innovation across regulated industries. As a ServiceNow Life Sciences partner, USDM helps organizations leverage AI responsibly to streamline processes, ensure compliance, and accelerate digital transformation. 💬 DM me if you’ll be there! 🔗 https://lnkd.in/g-xSFjbf
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Stop by Booth #537 at RAPS! Let’s Talk UDI, MDR, IVDR, and Syndication Are you ready for the next wave of regulatory change? Visit USDM and BYRD Health at booth #537 to explore strategies that keep your organization compliant—and confident. Let’s discuss: - Strategies for meeting EU MDR/IVDR deadlines - EUDAMED product data submission and system integration - Vigilance & post-market surveillance best practices - Global UDI alignment and multi-region syndication tools As regulators evolve their systems, USDM ensures your processes and technologies stay compliant and future-ready. #RAPS2025 #usdmlifesciences #BYRDHealth #RegulatoryInnovation #UDI #MDR #IVDR #LifeSciencesCompliance #EUDAMED Jay Crowley Jim Macdonell John Danese Lisa Om
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The life sciences industry is entering a new era—where AI, automation, and intelligent operations are no longer optional, but essential. Join USDM Life Sciences and Apps Associates at Oracle AI World 2025 for an exclusive Lunch & Learn to explore how regulated operations can be transformed with embedded intelligence, GxP compliance, and proven methodologies. Enjoy a private lunch, rich conversation, and access to proven strategies that bridge compliance with innovation in the cloud. Registration required here: https://lnkd.in/g2cNkKnh Kim Guihen John Danese Meghan Rutkowski Hovsep Kirikian Lisa Om Todd Hein Carla Roddy
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Don’t Miss This Exclusive Session with UDI Architect Jay Crowley Join USDM and BYRD Health for a pre‑conference workshop at RAPS Convergence 2025: 📅 Tuesday, October 7 • 2:00–4:00 PM • The Westin Pittsburgh This session—led by Jay Crowley, USDM VP of UDI Solutions and Services (formerly a key architect of the FDA's UDI system)—plus Ana Paula Caruso and Luis Chavez of BYRD Health—will offer a live demo of EUDAMED Syndication Solutions, guiding you through: - Mastering product data harmonization - Navigating regulatory timelines - Preparing for the 2026 mandatory UDI enforcement - Streamlining submissions to the UDI and Device Registration modules Seats are limited—registration required. Reserve your spot now! https://lnkd.in/g8aT67Tp Plus, don’t forget to stop by Booth #537 to chat with the team about UDI, MDR/IVDR strategies, post-market vigilance, and more.
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Don’t Miss This Exclusive Session with UDI Architect Jay Crowley Join USDM and BYRD Health for a pre‑conference workshop at RAPS Convergence 2025: 📅 Tuesday, October 7 • 2:00–4:00 PM • The Westin Pittsburgh This session—led by Jay Crowley, USDM VP of UDI Solutions and Services (formerly a key architect of the FDA's UDI system)—plus Ana Paula Caruso and Luis Chavez of BYRD Health—will offer a live demo of EUDAMED Syndication Solutions, guiding you through: - Mastering product data harmonization - Navigating regulatory timelines - Preparing for the 2026 mandatory UDI enforcement - Streamlining submissions to the UDI and Device Registration modules Seats are limited—registration required. Reserve your spot now! https://lnkd.in/g8aT67Tp Plus, don’t forget to stop by Booth #537 to chat with the team about UDI, MDR/IVDR strategies, post-market vigilance, and more.
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USDM Life Sciences reposted this
We’re honored to be named the GxP Partner of the Year at #BoxWorks 2025! USDM Life Sciences is proud to be recognized for helping life sciences organizations embed intelligent GxP compliance into their operations—accelerating speed to market, reducing risk, and enabling confident innovation. This award from Box reaffirms our commitment to empowering biopharma and medtech teams with proven compliance strategies and AI-driven automation for scalable, audit-ready success. See how USDM can evolve your regulated operations with Box: https://lnkd.in/gzt4M53m Read more about the award winners: https://lnkd.in/gntak-hr
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We’re honored to be named the GxP Partner of the Year at #BoxWorks 2025! USDM Life Sciences is proud to be recognized for helping life sciences organizations embed intelligent GxP compliance into their operations—accelerating speed to market, reducing risk, and enabling confident innovation. This award from Box reaffirms our commitment to empowering biopharma and medtech teams with proven compliance strategies and AI-driven automation for scalable, audit-ready success. See how USDM can evolve your regulated operations with Box: https://lnkd.in/gzt4M53m Read more about the award winners: https://lnkd.in/gntak-hr
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Third-party risk isn’t just a compliance issue—it’s a business continuity imperative. As life sciences organizations expand their digital ecosystems, the risk exposure from third-party partners intensifies. This article from USDM explores a proactive approach to identifying, assessing, and mitigating risks in your partner network—helping safeguard regulatory compliance and operational efficiency. 📈 At USDM, we help biotech, pharma, and medical device companies modernize risk management with audit-ready processes and intelligent tools that reduce vulnerabilities and accelerate innovation. 📖 Read more: https://lnkd.in/gdpuc2kq
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Let's connect at the Blue Mountain Summit 2025. USDM is excited to sponsor this year’s event in Durham, NC (Sept 8–10)! Meet our team on-site to explore how we help life sciences companies cut compliance costs and maximize their Blue Mountain investment. 👉 Book an on-site meeting with us today: https://lnkd.in/gTCZKxVd #USDMlifesciences #Compliance #BlueMountainSummit