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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, […]

Where does the user manual for an about-to-launch electronic product actually get written? At Hansem Global, it’s written in a secure workroom with the internet completely shut off — what we call the clean room. In here, even something a single search would normally solve has to be handled a different way. Here’s a day […]

In a secure workroom built for confidential documents, the last variable standing between you and a data leak is not the equipment. It’s the security awareness of the people inside. In Part 1, we looked at why some manuals are produced in a locked room. In Part 2, we looked at what that room is […]

For industrial machinery, the manual is a direct certification audit item — not a supporting document that a documentation team produces separately from the certification team. The EU Machinery Regulation (Annex III), ISO 20607, ISO 6750-1, ANSI/ITSDF B56.1, and EN 50126/50128/50129 — nearly every regulation and standard that applies to industrial equipment directly governs the […]

In our first article, we asked why some manuals are produced in a locked room. The locked room — the secure workroom — exists because there are risks an NDA alone cannot contain: risks that live in the environment itself. So what is that locked room actually made of? Does fitting a single lock turn […]

For a medical device, the manual itself can hold up market entry. In regulatory terms the user manual is the IFU (Instructions for Use) — a core document tied directly to product clearance, labeling, and usability evaluation, and one of the most common reasons an FDA 510(k) submission stalls. This second installment of our Manuals […]