Visual Aids in Medical Device IFUs: Why They’re a Strategic Asset, Not Just Design

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 […]

Redefining the Role of a Technical Writer: Beyond Documentation, Toward Strategic Enablement

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, […]

How to Market a Medical Device in the U.S.—What You Need to Know

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 […]

Plain Language in Action: Applying ISO 24495-1 to Public and Legal Documents

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, […]

How to Cut Localization Costs Without Sacrificing Quality: A Smarter Way to Produce Multilingual Manuals

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 […]

Preparing IFUs for FDA Submission: The 4 Essential Standards You Need to Know

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 […]

The New Frontier in Connected Cars: Why IVI Web Manuals Matter More Than Ever

As vehicles continue to evolve from transportation tools into fully connected digital platforms, In-Vehicle Infotainment (IVI) systems are taking center stage. They’re not just dashboards anymore—they’re the interface between the driver, the car, and the digital world. But as these systems become more complex, so does the need for better, smarter documentation. Traditional printed manuals […]

Digital Manual Accessibility Is No Longer Optional: How to Stay Compliant and Inclusive

In today’s regulatory landscape, ensuring that your product manuals are accessible to all users—including people with disabilities—is not just a good practice, but a legal necessity. Accessible manuals help you: Whether you’re a device manufacturer, a software provider, or a service operator, your manuals are part of your product. And increasingly, those manuals are delivered […]