Formatting Technical Documents

The Medical Device Iceberg: What’s hidden beneath your product is what matters most. Your technical documentation isn’t "surface work". It’s the foundation that the Notified Body look at first. Let’s break it down ⬇ 1/ What is TD really about? Your Technical Documentation is your device’s identity card. It proves conformity with MDR 2017/745. It’s not a binder of loose files. It’s a structured, coherent, evolving system. Annexes II & III of the MDR guide your structure. Use them. But make it your own. 2/ The 7 essential pillars of TD: → Device description & specification → Information to be supplied by the manufacturer → Design & manufacturing information → GSPR (General Safety & Performance Requirements) → Benefit-risk analysis & risk management → Product verification & validation (including clinical evaluation) → Post-market surveillance Each one matters. Each one connects to the rest. Your TD is not linear. It’s a living ecosystem. Change one thing → It impacts everything. That’s why consistency and traceability are key. 3/ Tips for compiling TD: → Use one “intended purpose” across all documents → Apply the 3Cs: ↳ Clarity (write for reviewers) ↳ Consistency (same terms, same logic) ↳ Connectivity (cross-reference clearly) → Manage it like a project: ↳ Involve all teams ↳ Follow MDR structure ↳ Trace everything → Use “one-sheet conclusions” ↳ Especially in risk, clinical, V&V docs ↳ Simple, precise summaries → Avoid infinite feedback loops: ↳ One doc, one checklist, one deadline ↳ Define “final” clearly 4/ Best practices to apply: → Add a summary doc for reviewers → Update documentation regularly → Create a V&V matrix → Maintain URS → FRS traceability → Hyperlink related docs → Provide objective evidence → Use searchable digital formats → Map design & mfg with flowcharts Clear TD = faster reviews = safer time to market. Save this for your next compilation session. You don't want to start from scratch? Use our templates to get started: → GSPR, which gives you a predefined list of standards, documents and methods. ( https://lnkd.in/eE2i43v7 ) → Technical Documentation, which gives you a solid structure and concrete examples for your writing. ( https://lnkd.in/eNcS4aMG )

AI won’t write your technical file for you—but it can slash drafting time when you use it well. Teams that treat ChatGPT or Copilot as a second pair of hands get clean, traceable text. Teams that treat it as an oracle spend the afternoon rewriting. Here are 12 workflow tips that separate time-savers from time-sinks. Use them, tune them, share them. 1. Define the role before the task ↳ “Act as a risk-management expert working to ISO 14971.” The model snaps to the right tone and cites the right clauses. 2. Anchor every prompt with the standard or regulation ↳ Paste “ISO 13485 §7.3.9” or “MDR Annex II 4.2” at the top. The answer mirrors the source’s structure. 3. Use your own template headings as scaffolding ↳ Feed the outline, AI fills gaps without inventing new sections you’ll just delete. 4. Add guiding context in square brackets ↳ [Class IIb active implant] keeps examples aligned with your risk profile. 5. Summarise, never use proprietary data ↳ AI can draft a concise performance section; you paste real data after export. 6. Keep sensitive data local ↳ If the platform retains prompts, strip patient IDs or unique device details first. 7. Run every output through a human “sense check” ↳ A knowledgeable reviewer asks: does this sentence survive a notified-body follow-up? 8. Cross-check references ↳ Ask the model to list its clauses, then open the standard yourself—false cites slip through. 9. Feed in guidance docs for nuance ↳ Drop MDCG 2020-13 or MEDDEV 2.7/1 Rev 4; the model can echo regulator phrasing that auditors trust. 10. Limit each prompt to one deliverable ↳ “Create an executive summary” and “draft a PFMEA” go in separate chats; clarity in, clarity out. 11. Log prompt-response pairs in your Technical Documentation ↳ Treat them like meeting notes, future auditors can see how text arrived and why you accepted it. 12. Version-lock your AI model for each project phase ↳ Save the full output now; a later model update may answer differently. A well-directed model speeds the work; a poorly directed one doubles it. P.S. Are you using AI as your virtual assistant for Techdoc generation? ⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡ MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference. I’m Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed. Let’s connect and collaborate to streamline regulatory work for everyone! #automation #regulatoryaffairs #medicaldevices

How the text appears on your reader’s page or screen matters. Document design, white space, and typography can all reflect on your credibility. These are the silent persuaders: 1⃣ Choosing the Right Fonts When it comes to fonts, the choices you make can impact both the readability and professional appearance of your document. Your goal should be to choose fonts that make your text easy to read while reflecting the serious nature of the material. 2⃣ Styling and Emphasizing Text Italics often serve as a better tool for emphasizing case names and other critical details in your text. Unlike underlining, italics do not interfere with any descenders in the letters, ensuring that the text remains clean and clear. 3⃣ Punctuation and Text Spacing Consider joining the one-space crew if you aren’t a member already. In our digital age, there’s no need to use two spaces after a period, a practice inherited from the typewriter era. Modern fonts provide sufficient space after a period already. 4⃣ Mastering White Space White space, or negative space, refers to the unmarked portions of a page. It’s not empty space, it’s a tool that can enhance your document in several ways. Consider the humble paragraph break: a single line of white space that provides a visual cue of a new thought or idea. 5⃣ Layout and Alignment The layout of your document, including margins, alignment, and line length, can also affect readability. Left-aligned text is typically the easiest to read, as it maintains a consistent starting point for each line. Ensure you have ample margins. Designing your documents requires some work outside of the normal words and sentences that legal writers most often focus on. But form can affect function. So your document’s design is worth investing in. - I’m Joe Regalia, a law professor and legal writing trainer. Follow me and tap the 🔔 so you won't miss any posts.

Want to make your technical #documentation more effective? Keep it skimmable! I've found that using short, simple sentences and compact paragraphs makes documentation infinitely more useful for readers. When developers need answers, they scan documentation quickly, looking for specific information. By breaking content into clear sections with descriptive headings, you create natural "jumping-off points" that help readers navigate directly to what they need. Think of good headings as signposts guiding your readers through the content. Simple language and concise paragraphs reduce cognitive load, making your docs easier to understand, especially for non-native English speakers (which is an added accessibility win). Remember: technical documentation isn't creative writing. Its purpose is to convey complex information clearly and efficiently. #TechnicalWriting #Documentation #DeveloperExperience #TechComm #WritingTips #technicalwriter #InformationDevelopment #InformationDeveloper

💡 Formatting is communication. I can't tell you how many times I have heard someone say, "We have documentation for that..." They are frustrated that employees are not using their documentation. The insinuation is that if only their employees weren't too lazy to read the documentation, they wouldn't have so many problems. But then we look at the documentation. It is a wall of words with foundational and actionable knowledge jumbled together in a way that makes it almost impossible to parse through. Jonathan DeVore, Brooke McGavin, and Victoria Perez are pros at reformatting these guides. It's like watching one of those home remodeling shows. They take something that is almost unusable and help clients turn it into a guide that is findable, followable, and scannable. And 90% of what they do is: 1. Separate foundational and actionable information 2. Improve formatting to make it more scannable And all of a sudden, employees start using the documentation. Words alone don't communicate. Formatting will either hide or uncover the knowledge employees need. Don't neglect it. #knowledgeops #findandfollow

Ever hit a wall of text and immediately tune out? That’s what happens when writing lacks structure. Good documentation isn’t just about what you say— it’s about how you present it. Here’s what makes content instantly clearer: ✅ Chunking – Break information into small, logical sections. One idea per chunk. ✅ Lists – Highlight key details instantly. Ordered for steps, unordered for related ideas. ✅ Headings – Act as street signs. Keep them short, clear, and easy to scan. When all three work together, the reader doesn’t have to think—they just find what they need. Before you publish, ask yourself: Can someone scan this and get the key points in seconds? If not, it’s time to restructure. Follow Andrew Eroh for Technical Writing Insights   #TechnicalWriting #TechComm #Documentation #UserExperience #ClearCommunication #WritingTips #TaskBasedWriting #ProcessImprovement #WritingProcess #EngineeringDocs