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As products become more complex and the number of localized languages increases, managing documentation quality—especially for user manuals and technical documents—has become significantly more challenging. Manual quality checks often fail to catch recurring issues, and under tight deadlines, even minor oversights can result in costly delivery errors. At Hansem Global, we developed the QA Suite, […]

Technical manuals are no longer just instructional materials—they have become critical tools for ensuring product safety, regulatory compliance, and customer trust. Today, new global standards tied to environmental regulations, digital accessibility, and ESG (Environmental, Social, and Governance) initiatives are fundamentally changing how documentation is created and delivered. This article explores how these evolving requirements impact […]

In the U.S. and other regulated markets, Instructions for Use (IFUs) for medical devices must meet high standards. Such a practice is mandated not only for safety and clarity, but also for regulatory compliance and global usability. A growing number of manufacturers now recognize that visual aids aren’t just design enhancements. They are essential tools […]

In manufacturing and high-tech industries, documentation often goes unnoticed—until it fails. A missing installation step, unclear safety message, or poorly structured manual can lead to operational delays, safety incidents, or excessive support calls. This is why technical writers play a pivotal role—not just as writers, but as strategic enablers of product success. At Hansem Global, […]

The U.S. remains one of the most competitive and tightly regulated markets for medical devices. But even with a high-quality product, many companies face costly delays—not because of flaws in the technology, but due to gaps in documentation or misunderstanding of regulatory requirements. That’s why Hansem Global, a leading provider of multilingual documentation and regulatory […]

In recent years, there has been a global push toward making documents easier to read and act on, especially in fields like government, insurance, finance, and healthcare. Many of these sectors are still producing overly complex, formal, and jargon-heavy materials, which can confuse or alienate their intended audiences. As a response to this widespread challenge, […]

For mid-sized manufacturers in the U.S. market, managing product documentation in multiple languages is an ongoing and often costly challenge—especially when launching frequent product variants or regional model updates. Every new manual, every language, and every update can result in ballooning translation costs, delayed time-to-market, and consistency issues across versions. But what if the process […]

When preparing a medical device for the U.S. market, the Instructions for Use (IFU) is not just a user manual—it’s a regulatory document subject to FDA scrutiny. A compliant IFU must clearly communicate safe and proper product use while meeting both FDA requirements and international standards. To support this critical task, Hansem Global and Amin […]