Hansem Global

FDA clearance is a milestone, not the finish line. Before a medical device can legally reach U.S. customers, it has to meet a series of requirements that many small and mid-sized manufacturers don’t see coming. That’s why we’re teaming up with Amin Wasserman Gurnani (AWG) for a free webinar: “HOW TO GET IT RIGHT: Legally Launching a Medical Device in the U.S.” 📅 November 10, 2026 | 2:00–3:00 PM ET (November 11, 2026 | 4:00–5:00 AM KST) Our Managing Director, Brian Cho, PMP, joins Neil O'Flaherty, AWG Partner with 36+ years representing Class I, II, and III device companies, to walk through the essentials: labeling, UDI, establishment registration and device listing, marketing applications, quality system requirements, and medical device reporting. The session covers more than what’s required. You’ll also learn when and how each requirement applies, plus practical guidance on timelines, risk, and avoiding unnecessary regulatory scrutiny. If you’re facing FDA requirements for the first time, or expanding into the U.S. market, this hour is for you. Register here: https://lnkd.in/gx6DbTBQ #MedicalDevices #FDA #RegulatoryAffairs #MedTech #UDI

Your tourism website speaks 40 languages. But does it speak "Asia"? 🌏 Translating travel content is easy. Getting Asian travelers to connect with it is the hard part. Here's what generic translation tends to miss: 🙇 Korean & Japanese: Honorific register matters. A welcome message needs a different tone than a promo banner. Get it wrong and you sound either cold or careless. 🏮 Chinese isn't one market: Simplified serves mainland China. Traditional serves Taiwan, Hong Kong, and Macau. The differences go well beyond the characters, down to vocabulary and travel terms. 🌴 "Southeast Asia" isn't one market either: Vietnamese, Thai, Indonesian, and Malay each have their own conventions, writing rules, and traveler expectations. A single regional approach won't serve them all. 📍 Names travelers search for: Hotel names, landmarks, and brands need consistent transliteration. If travelers can't search for a place in their own script, they'll never find it. The fix doesn't have to mean rebuilding your entire localization program. Bring in a partner who can take on the Asian portion and run it with consistent terminology across every touchpoint. At Hansem Global, we've localized property descriptions, promotional copy, and website content for two of the world's largest online travel agencies. ✈️ 📖 Read the full article: https://lnkd.in/gAbABXrE #Localization #TravelTech #Hospitality #Tourism #AsianMarkets #HansemGlobal

ONE unclear warning in the English source. THIRTY manuals ship with the same defect. Documentation teams know this pattern. A reviewer in one market flags a confusing instruction, the team traces it back, and the problem was sitting in the source all along. Translation QA can confirm the target matches the source. It cannot fix a source that was wrong to begin with. That is why WHERE a localization partner started still matters. Most providers grew out of translation and added services around it. Hansem Global took the opposite route: we wrote, illustrated, and designed manuals first, then added localization on top of that foundation. The order left habits that never went away. 🔍 Source files get reviewed before translation begins, so a defect gets corrected once instead of thirty times. ⚙️ When 50-language production outgrew human eyes, we automated the checking. That work became a QA Suite of 60+ tools still running today. 👉 The full story: https://lnkd.in/gWy9bEbA #TechnicalDocumentation #Localization #TechnicalWriting #ManualLocalization

📢 "The translation quality is bad", but is the translator really the problem? Brian Cho, PMP, Director at Hansem Global USA, raises a question worth sitting with in his latest piece for MultiLingual Media: 🔍 "Translation cannot add quality that the source does not contain." When translations disappoint, the instinct is to switch vendors. But if the new one produces the same flaws, the problem was never the translation step. It's the source. 🤔 ⚠️ No translator can fix a source with ambiguous writing, inconsistent terminology, poor structure, or non-compliance with standards like ANSI Z535.6. 🤖 AI doesn't change this either. It just reproduces a flawed source faster and cheaper. 💡 The fix: design manuals to be translated, not just translate them. Clear authoring, modular structure, and terminology management are where real quality starts. Read the full article 👉 https://lnkd.in/gDG5eKCe #Translation #Localization #TechnicalWriting #HansemGlobal #GlobalContent

Your manual has two kinds of drawings. Only one has rules.📐 Screenshots, icons, exploded views: most drawings in a manual just need to look right. But a few of them aren't judged on how they look at all. A few are not. Safety pictograms follow fixed rules under ISO 3864 and ISO 7010, and getting the shape wrong costs the page its meaning before anyone reads the caption.⚠️ The reader takes in the surround shape before anything inside it. A circle with a 45° bar is a prohibition. A triangle is a warning. A circle with no bar is a mandatory action. Mix those up - a prohibition drawn as a blue square, say - and the first signal the reader gets contradicts the message. We've made this mistake ourselves: one of the examples in the full article https://lnkd.in/gk6AyPH7 is a manual we produced about a decade ago, before we knew the surround shape carried meaning. The rules hold up even without color. Printing in black and white is a permitted constraint, shape and contrast still carry the message. Losing the shape is not permitted, at any budget. The practical fix is simpler than most teams expect: check ISO 7010's registered catalog before drawing anything new. Most hazards on an industrial floor already have finished, standardized artwork waiting. Reach for the ISO 3864 grammar only when the catalog comes up empty.✅ Want a second pair of eyes on your safety pages? Reach out to Brian Cho, PMP or [email protected]. Full story: https://lnkd.in/gk6AyPH7 #SafetyPictograms #ISO3864 #ISO7010 #TechnicalDocumentation #ManualCompliance #HansemGlobal

Hansem Global ranks 37th on the CSA Research Verified 100 (2026). 🏆 Up twelve places from 49th last year, and the ranking itself changed shape. CSA Research widened its scope this year from language service providers to global content solutions providers: companies that create the content, ship it in every language, and keep it current as products change. 📈 Most of the industry still sits in one of two camps: translation-led companies that rarely build a real writing team, and documentation-led companies that rarely build translation in-house. Either way, the client ends up coordinating the handoff, and absorbing the risk when something falls through it. Hansem Global built both sides to full strength over 36 years, authoring in English from the start, localizing into 100+ languages, and applying standards like IEC/IEEE 82079-1 and ANSI Z535 during authoring, not after translation. More than 170 specialists now run this as one operation across Korea, the US, and Vietnam. 🌍 37th is where that structure landed this year. ✅ Full story: https://lnkd.in/gF4ZKB4a #CSAResearch #GlobalContentSolutions #TechnicalDocumentation #Localization #HansemGlobal