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Already active in several U.S. regions, AmeXio has earned a strong reputation over the past 15 years through its work with leading pharmaceutical and MedTech companies in North America and Europe. With rising regulatory scrutiny and compressed product timelines, AmeXio is now scaling its U.S. operations under the leadership of Dan Schneider, Managing Director for North America.
“We’ve been successfully partnering with U.S.-based MedTech clients, and now we’re expanding that footprint to meet broader demand,” said Schneider. “Structured content is a natural fit for this industry’s fast-paced, compliance-heavy environment—making it a renewed strategic focus for us.”
AmeXio’s SCM approach utilizes XML DITA and other XML standards, supported by Component Content Management Systems (CCMS), to deliver modular, reusable content frameworks. These models enhance content traceability, streamline regulatory submissions, and eliminate redundant authoring—all while improving audit readiness across geographies. For medical device manufacturers navigating multilingual labeling, shifting regulations, and rapid product cycles, SCM offers measurable gains in efficiency and accuracy.
What It Means for Customers
For current and prospective clients, AmeXio’s expanded U.S. presence translates into faster access to expert consulting, localized support, and scalable solutions tailored to regulatory content challenges. By adopting SCM, organizations can:
- Reuse approved content across multiple products, geographies, and media.
- Cut documentation timelines by up to 50%.
- Avoid inconsistencies that trigger audit flags or delay approvals.
- Accelerate translation and localization using structured, metadata-rich assets.
- Improve precision and consistency in AI/LLM outputs through uniform content models
These benefits significantly reduce manual workloads, improve cross-departmental alignment, and provide a foundation for long-term digital transformation. Whether supporting FDA compliance, launching new product lines, or harmonizing digital and print outputs, AmeXio’s methodology empowers teams to deliver content at the speed of business.
While the medical device industry is the company’s initial priority in this phase, AmeXio also supports adjacent sectors including biopharmaceuticals, diagnostics, and digital health technologies.
Upcoming Webinar: Are You Audit Ready?
To support this strategic expansion, AmeXio will host a MedTech webinar on Tuesday, July 22 at 1p.m. EDT titled, “Are You Audit Ready? - How to Get Audit Ready with Structured Content Management.” The session will explore how structured content frameworks can enhance audit preparation, reduce delays, and elevate content governance across regulated environments.
Webinar highlights include how to:
- Design and deploy audit-ready documentation workflows.
- Eliminate duplication across labeling, regulatory, and quality teams.
- Reuse validated content across product lines and international markets.
Click here to register for the July webinar.
About AmeXio Group
AmeXio Group is a global IT Services consulting and technology firm specializing in structured content management (SCM), enterprise content management (ECM), and content governance for regulated industries. Serving clients in pharmaceuticals, MedTech, and beyond, AmeXio helps organizations modernize how they create, manage, and distribute critical content across markets. Visit www.amexiogroup.com for more information.
Sherri Hughes-Smith
AmeXio Group - US
+1 720-557-0027
email us here
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