USDM Life Sciences

EUDAMED is live — and the deadlines are real.

May 28 for new devices. November 28 for existing ones. No grace period, no unlock.

Jay Crowley explains exactly what medical device companies need to do right now — in under 10 minutes.

Watch →

EUDAMED Has Landed: What Medical Device Companies Need to Know Now EUDAMED — the European database on medical devices — achieved minim...

A global CDMO needed to scale quality operations across sites without slowing manufacturing or losing regulatory confidence. USDM helped build an AI-enabled digital quality model — combining Azure, OpenAI, a custom knowledge graph, and Veeva Quality integration — to power deviation investigations, SOP interpretation, and real-time KPI visibility.

The results: ~40% faster deviation cycle times, ~60% better SOP review efficiency, and up to 900% projected 3-year ROI.

See how quality excellence became a scalable, AI-enabled advantage:

Driving Quality Excellence and Operational Efficiency for a Global CDMO Case study: Discover how a global CDMO built a scalable, AI-enabled quality model--driving measurable impact, regulatory confidence, and long-term differentiation.

AI only creates value in life sciences when it's embedded in real work — not bolted on as a demo. USDM helps regulated teams deploy AI agents into intake triage, drafting, review, knowledge retrieval, evidence capture, and exception handling across Quality, Regulatory, Clinical, Manufacturing, Commercial/Medical, and IT/Ops. The pattern: bounded agent roles, explicit human decision points, and full reviewability.

Explore how AI deployment gets real →

AI Agents for Regulated Workflows | USDM AI delivers value when agents are embedded in real work. USDM helps regulated teams deploy AI into intake triage, drafting, review, knowledge retrieval, evidence capture, and exception handling so work moves faster across Quality, Regulatory, Clinical, Manufacturing, Commercial/Medical, and IT/Ops.

USDM is proud to sponsor Glean:GO 2026 — Glean's flagship enterprise AI conference — August 26–27 in San Francisco.

We'll be on the ground helping life sciences teams explore how governed Work AI can connect enterprise knowledge, support traceability, and move regulated organizations from AI experimentation to real business impact.

Topics we're ready to discuss: AI readiness, GxP-compliant Glean implementation, inspection readiness, SOP analysis, and validation strategy.

Heading to Fort Mason? Let's connect.

USDM at Glean:GO 2026 USDM is sponsoring Glean:GO 2026, Glean’s flagship enterprise AI conference for leaders building the next generation of AI-powered work.

Complaints, CAPA, regulatory submissions, adverse events — all moving through disconnected tools. Sound familiar?

Our on-demand webinar with ServiceNow shows how Compliant Contact Center (CCC) turns ServiceNow into a GxP-ready workflow engine for life sciences — connecting regulated intake, triage, routing, and audit-ready evidence in one operating model.

Watch on demand →

ServiceNow as the Compliant Workflow Engine for Life Sciences Webinar: Watch this on-demand webinar with ServiceNow and USDM Life Sciences to see how Compliant Contact Center connects complaints, CAPA, regulatory submissions, and other GxP-relevant workflows in an audit-ready ServiceNow operating model.

Medicinal product information is moving from static documents to structured, exchangeable data — and HL7 FHIR is at the center of that shift.

But FHIR readiness isn't just a mapping exercise. It requires data governance, cross-functional alignment, validation strategy, and an operating model that can support regulatory accountability at scale.

USDM's latest blog breaks down what life sciences teams need to prepare — and why getting the data foundation right now sets the stage for AI readiness later.

Read the blog:

HL7 FHIR and ePI: Why Structured Product Information Is the Next Step in Regulatory Modernization Blog post: Why HL7 FHIR-based electronic product information requires more than data mapping, and how life sciences teams can prepare the governance, validation, and operating model behind structured medicinal product information.