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The phrase regulatory affairs teams reach for most often, “regulatory compliance review,” covers at least three different jobs. Deciding whether the product can enter the market, obtaining the testing and certification, and verifying that confirmed regulatory items actually landed in the documents. The first two have reasonably clear owners. The confusion starts at the third. […]

Product manuals and instructions for use carry dozens of items that exist because a regulation requires them: certification marks, mandated warning text, manufacturer and importer details, disposal notices, language requirements. Ship to more than ten markets and those items multiply into hundreds of combinations. If nobody owns the list, a single rule change can take […]

Most drawings in a manual are the writer’s call. A few are not. Those few have a fixed shape, and getting them wrong costs the document its credibility. This article covers where illustration and safety pictogram part ways, and which rules apply once you cross that line. 1. Instructional illustration vs. safety warning image User […]

Since 2012, Hansem Global has run three secure workrooms, one for each client organization, for 14 years, with zero data breaches. What produced that record isn’t the physical infrastructure you can buy with capital, but the operational know-how and security culture that only time builds. You can buy the space; you can’t buy a 14-year […]

In July 2026, Vietnam’s drug administration ordered ten imported cosmetics products pulled from distribution, recalled, and destroyed. The importer was fined and barred from filing any new product registrations for six months. The products were Korean, the market was Vietnam, and the category was beauty. For a manufacturer of medical devices, industrial equipment, or electronics […]

This series set out to remind those responsible for manufacturers’ manuals of one thing: the manual is the certification record a regulator reviews first, not material the user never reads. In medical devices the manual is reviewed directly under FDA 510(k). Industrial machinery treats it as a certification audit item, and in robotics it is […]

A typical multilingual localization project leans on cloud-based translation memory (TM), search engines, and external collaboration tools. Translators, PMs, DTP specialists, and QA reviewers share files in real time and keep the work moving. Projects in Hansem Global’s secure workroom work a little differently. The work happens inside an environment where outside network access is […]

A robot manufacturer’s manual is, before it is a user guide, the first document a certification authority examines. As Part 1 of this series established, the manual and its labeling are themselves the object of certification review, and robot safety regulations specify exactly what must appear — and in what form — in the manual, […]