Developing Technical Documentation Skills

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 )

Regulatory Affairs Isn’t Guesswork—It’s 12 Concrete Skills You Can Practice Miss even one and you may ship a device that stalls at the notified-body gate. Skip the craft and you risk: ❌ Gaps in your Technical Documentation ❌ Months lost to “please clarify” letters ❌ Costly redesigns when risks surface too late Below is your EU MDR cheat sheet of 12 hard skills—the toolbox every RA newcomer should build and every veteran should keep sharp. 👇 1️⃣ Draft a Crystal-Clear Intended Purpose ↳ One paragraph that anchors classification, claims, and clinical strategy. 2️⃣ Map Devices to Annex VIII Rules ↳ Class I ↔ III decisions drive every downstream obligation. 3️⃣ Build a GSPR Evidence Matrix ↳ Link each requirement to test reports, standards, and documents. 4️⃣ Architect Annex II Technical Documentation ↳ Hyperlinked PDFs, executive summaries, and version control—readable at speed. 5️⃣ Construct a Risk Management File (ISO 14971) ↳ Hazard analysis, FMEA/FMEDA, and risk–benefit traceability in one flow. 6️⃣ Write Clinical Evaluation Plans & Reports (MEDDEV 2.7/1 rev. 4) ↳ Literature strategy, weighting, and CER conclusions auditors can follow. 7️⃣ Run Usability Engineering per IEC 62366-1 ↳ Use scenarios, summative testing, and residual-risk linkage. 8️⃣ Author ISO 13485 QMS Procedures ↳ Clear ownership, KPI triggers, and revision history—no shelfware SOPs. 9️⃣ Plan Post-Market Surveillance & Craft PSURs ↳ Data sources, statistical methods, and proactive trend detection. 🔟 Manage Vigilance & FSCA Workflows ↳ 15-day serious-incident clock, CAPA linkage, and global variants. 1️⃣1️⃣ Document Software Lifecycle per IEC 62304 ↳ Software Risk Classification, verification reports, and traceability logs. 1️⃣2️⃣ Assess Regulatory Change Impact ↳ Scan new MDR amendments, standards updates, and guidance—but, crucially, map them to your devices and QMS. Master These Skills and You Gain: ✅ Faster, cleaner CE-mark reviews ✅ Fewer design surprises late in development ✅ A reputation as the “go-to” RA problem-solver Which hard skill are you sharpening next—or which one would you add to the list? ---------------------------------- 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

Software Architecture Documentation Good architecture is as much about communication as it is about code. A well-documented architecture bridges the gap between vision and implementation, aligning teams and ensuring longevity for your systems. Software architecture docs are the blueprint for understanding, talking about, and changing a system’s design. It helps teams work together better by keeping track of important decisions and details. Good docs make it easier to scale, debug, and improve the system, plus everyone understands what’s going on. Keep your docs short, useful, and organized (like using ADRs, RFCs, etc.). Think of them as code—always updating. Here are a few ways of writing and managing one: 1️⃣ Architecture Decision Records (ADRs) Every choice in architecture has consequences—technical, operational, and cultural. ADRs provide a lightweight, structured way to document why decisions were made, the trade-offs considered, and the context at the time. They’re invaluable for future teams to understand the why behind the how. 2️⃣ Request for Comments (RFCs) Collaboration is key for a sound architecture. RFCs enable open dialogue by inviting feedback on proposed changes before implementation. They create a culture of shared ownership, making the architecture a living, evolving entity rather than a rigid blueprint. 3️⃣ Event Storming When designing complex systems, especially those using event-driven architectures, event storming helps. By focusing on business events, you uncover hidden domain knowledge, identify bottlenecks, and align stakeholders—technical and non-technical alike. 4️⃣ The C4 Model Clarity is king. The C4 model—Context, Containers, Components, and Code—provides a zoom-in/zoom-out approach to documentation that scales with your audience. Whether you’re talking to a developer or a CEO, the C4 model ensures they see what they need to see. To summarize Architecture documentation is significantly more than mere paperwork; it serves as the crucial bedrock upon which resilient, scalable, reliable and maintainable systems are built and sustained. The proper execution of this process will significantly enhance your team’s ability to work at an accelerated pace, all while ensuring the maintenance of high standards and minimizing the potential for errors. What are your go-to techniques for documenting architecture? #SoftwareArchitecture #Documentation #ADRs #RFCs #EventStorming #C4Model

Technical Writers Do Not “Write Too Technical.” That Is the Job Misunderstood. There is a persistent misconception about technical writing that keeps resurfacing. The idea that technical writers write at their own level and forget the end user. That is not a failure of technical writing. It is a fundamental misunderstanding of what technical writing actually is. Technical writers do not write for themselves. We write for the person who needs to complete a task successfully. That audience changes constantly. If a user struggles because of jargon, unclear steps, or poorly broken-down processes, the problem is not that the content was technical. The problem is that the content was not written for that user. Technical writers almost never write for a single audience. Within the same product, we may write: • Developer documentation that requires precise technical language • Administrator guides for power users • Task-based instructions for non-technical end users • Internal documentation for support, sales, and leadership Same system. Different readers. Different context. Different language. Knowing how to shift between those registers without losing accuracy is not accidental. It is a core professional skill. Writing clearly for people with less technical context is hard. That is why it is a role, not an afterthought. When documentation works, users do not feel confused or condescended to. They simply succeed. That is not dumbing things down. That is good technical writing.

Most teams think a document is done when it is written. Technical writers know the real work happens after the last word. Here are 6 things technical writers check before calling a document done (that most teams assume are already fine): 1. Is every step actually testable? → Can a real user execute step one and get the result the doc says they will get? → Are the expected outcomes described, or just the actions? → A document full of instructions that cannot be verified is not done. It is a draft with a deadline. 2. Does the structure follow the user's goal or the product's logic? → Is the document ordered around what the user needs to accomplish, or how the product was built? → Do the sections map to tasks, or to features? → Engineers document how it works. Technical writers document how to use it. 3. Are all terms used consistently? → Is one thing called one name, every time, in every step? → Do the terms in the document match the terms in the product interface? → Inconsistent terms create silent confusion that users blame on themselves, not the docs. 4. Has every assumption been removed or explained? → Does any step require knowledge that was never introduced in this document? → Are there prerequisites the reader is expected to know but never told? → Every unexplained assumption is a place where a user quietly stops trusting the product. 5. Does it still make sense without the screenshots? → If every image disappeared, would the text still guide the user through? → Is any critical information only visible in the image and not in the text? → Visuals support. Text carries. If the text cannot stand alone, the document is not done. 6. Would a new user know what to do next? → Is there a clear next action at the end of every section, not just the document? → Are there dead ends where the document stops and leaves the user without direction? → No dead ends. No "now what?" moments. Done is a standard, not a feeling. Most teams call a document done when it is written. Technical writers call it done when it works for the person who has never seen it before. Which of these does your team skip most often? Drop the number (1-6) in the comments. 👇 Save this for the next time someone says the document is ready to publish. Reshare this with a team that works closely with a technical writer. Want more career insights for writers: 1. Follow Joshua Gene Fechter 2. Like the post 3. Repost to your network

You write your docs in Markdown (or mdx), right next to your code... You're already winning. It's the best way to keep docs current and part of the development workflow. But let's be honest. Sometimes that docs/ folder becomes a chaotic mess of untitled files and outdated notes that only you understand. Writing docs next to code is the first step. Making them useful is the master stroke. Here are 5 tips to level up your docs-as-code game. 1️⃣ Document the "Why," Not Just the "What." Your code is the "what." It's explicit. Don't write docs that just re-explain what a function does. Your code should be clean enough for that. Write down the why. "Why did we choose Kafka over RabbitMQ for this service?" "What business logic led to this weird edge case?" A single sentence of context is worth 100 lines of code comments to the next developer. 2️⃣ Write for Your Future, Stressed-Out Self. Imagine it's 3 AM, production is on fire, and you haven't touched this service in six months. What would you need to know right now? Write that down. How to run it locally. Key troubleshooting commands. Links to relevant dashboards. Your future self will thank you. 3️⃣ Automate Your Diagrams. Stop screenshotting hand-drawn diagrams and checking them into the repo. They're outdated the moment you commit them. Use text-based diagramming tools like Mermaid.js or PlantUML. You can write them directly in your Markdown files. They are version controlled with your code and always render the latest version. It's a total game-changer. 4️⃣ Create a Consistent Structure. Don't just create random .md files. Agree on a simple folder structure for every service/module. For example: /docs 01_getting_started.md https://lnkd.in/d4bix8Eh 03_runbooks/ rollback_procedure.md Consistency turns a messy folder into a predictable library. 5️⃣ Sync to a Portal. Don't Trap It in the Repo. This is the most critical tip. Your docs are useless if PMs, support, and new hires can't find them without cloning a repo. This doesn't mean you stop writing docs in Git! Use a modern knowledge portal (like Archbee) that automatically syncs with your repository. You get to stay in your IDE, writing in Markdown. Everyone else gets a central, searchable, user-friendly website. It's the best of both worlds. --------------- Docs-as-code isn't just a trend; it's the standard. But making those docs discoverable, structured, and full of context is what separates good engineering teams from great ones. What's your favorite docs-as-code tool or trick? I'm a huge fan of Mermaid.js for diagrams. Your turn. 👇

I thought learning Excel, SQL and Power BI would be the hardest part of my data analysis journey until I had to document my projects. From the start, I struggled with structuring my project documentation. I didn’t know what to include, how much detail was enough, or how to present my work in a way that made sense to others. Every attempt felt incomplete, and the more I compared my work to others, the more frustrated I became. But then I realized something, good documentation isn’t about sounding technical or using beautiful visuals. It’s about clarity. I started following a simple structure: project title, project overview, problem statement, data source, methodology, key insights, and recommendations. With this, everything clicked. Now, my documentation not only makes my projects look polished but also helps me confidently explain my work. If you’re struggling with project documentation, you’re not alone! How do you approach it? Abimbola Arowolo #21DayLinkedinChallengeWithAbimbola #DataAnalytics #ProjectDocumentation #TechCommunity

Technical writing used to be about writing. Now it's about architecture. The shift happened quietly. Your documentation needs to: Feed the support chatbot without breaking it. One writer wrote "refer to the previous section." The AI couldn't answer basic questions for a week. Pass accessibility audits without last-minute panic. Digital-first means screen-reader-first. Scale across products without recreating content. Modular or nothing. Survive the regulatory maze. Digital delivery that's actually compliant, not just convenient. The writers who thrive in this environment aren't necessarily the best prose stylists. They're the ones who think in systems. Content models. Metadata architecture. Structured authoring. Terminology governance. Sounds like data engineering because it partly is. The job title says "writer." The job description is increasingly "information architect." Is your team building for this shift, or still optimizing for the old model? #TechnicalWriting #Documentation #AI #DigitalTransformation

Think you’ll remember every step of your bioinformatics project 3 months from now? You won’t. And it will cost you. 1/ In bioinformatics, you juggle dozens of datasets, run endless scripts, tweak parameters. It’s chaos. Without notes, it’s disaster. 2/ Documentation isn’t for now—it’s for the day you open an old folder and can’t recall why you even made it. 3/ You need to record: The question you’re answering Why the analysis matters Data sources & versions Every command you ran 4/ Forgetting these isn’t rare—it’s inevitable. The human brain isn’t built for 10,000 command-line details. 5/ Example: Without a note, you won’t know if STAR --outFilterMismatchNmax 2 was a choice or a copy-paste from Stack Overflow. 6/ Good documentation is a time machine. It lets you drop back into the exact mental state you had when you ran the analysis. (I was saved by my documentation yesterday, again!) 7/ And it’s the heart of reproducibility. If no one can follow your steps, the science is dead. 8/ Start simple: Keep a README in every project Write clear markdown notes for each step Track changes with Git or GitHub 9/ Expand with automation: Turn repeated steps into scripts Use Jupyter or RMarkdown to mix code + explanation Build pipelines in Nextflow or Snakemake 10/ Example: A README can say: “Aligned reads with STAR v2.7.8a using GRCh38. See align. sh for exact parameters.” That saves you days later. 11/ Example of automation: Instead of typing 5 commands for every sample, make process_sample.sh and run it with ./process_sample.sh sample1. 12/ More proof: Projects that use Snakemake or Nextflow don’t just run faster—they explain themselves. The pipeline is the documentation. 13/ Key takeaways: Documentation is a survival tool Automate where possible Without reproducibility, your science is meaningless 14/ If you work in bioinformatics, your future self is your most important collaborator. Write for them. I hope you've found this post helpful. Follow me for more. Subscribe to my FREE newsletter chatomics to learn bioinformatics https://lnkd.in/erw83Svn

A short while ago, I posted about how you can truly strengthen your #ServiceNow developer resume/CV in 2026. Some of those core pieces involved proper and modern documentation. Since then, I've had a few people reach out asking for more information. So...here you go! To make things easier to understand, good documentation tends to happen across three layers. Each one serves a different purpose. - Code level (for developers) Think of this as being closest to the work itself and usually include tools/artifacts like: JSDoc, clear and purposeful code commenting, and README files if you're using source control. This is what helps the next developer understand what you've built without having to reverse engineer it. - Process/System level (for teams and stakeholders) This layer is where most people think documentation lives. It includes integration documentation, solution architecture docs, data mappings, API specs, error handling approaches, runbooks, and support guides. Confluence or SharePoint are still commonly used instead of standalone Word docs. Or Jira/ServiceNow for linking the documentation directly to the work. Notion is also used, but the use cases seem to vary. - Visual level (shared understanding - dev/architect) This is the layer that's most often skipped, but, ironically, is the most effective! Here is where process flows, integration, and sequence and system context diagrams live. Visio was king here (and still is to some degree in the Fed space), but real-time collaborative cloud tools such as Lucidchart, draw.io, and Miro (for workshops and early discovery) have become very popular. I'd highly recommend becoming familiar with these three levels and start baking them into your habits! How are you structuring this today? Are you leaning more into one of these layers than the others? What tools do you use? #ServiceNowCommunity #ServiceNowDeveloper