Technical Documentation Essentials

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 )

The closer technical writers are integrated with engineering teams, the better the documentation becomes. When writers are treated as essential members of the development process rather than an afterthought, they can create more accurate, timely, and valuable documentation that truly serves both users and developers. Docs-as-code is one of the most effective ways to achieve this integration. By using the same tools and workflows as developers, technical writers can participate directly in the software development lifecycle, catch documentation needs earlier, and maintain docs with the same rigor as code. For teams looking to get started with docs-as-code, here are some excellent tools to consider: Static Site Generators: - Jekyll (particularly with GitHub Pages) - MkDocs - Hugo - Sphinx (especially for Python projects) Documentation Linters: - Vale for style/grammar checking - markdownlint for Markdown consistency - awesome-lint for README files Version Control & Collaboration: - GitHub/GitLab for repository management - Pull request workflows for doc reviews - GitHub Actions for automated doc testing - LEARN GIT VIA COMMAND LINE The investment in learning these tools pays off quickly in improved #documentation quality, better collaboration with developers, and more efficient workflows. Most of these tools are open-source and well-documented, making them perfect for teams just starting their docs-as-code journey. #TechnicalWriting #DocsAsCode #Documentation #TechComm #DeveloperDocs #TechnicalCommunication

Good technical documentation isn’t just a nice-to-have—it’s the backbone of scalable, efficient operations. Without it, teams waste time reinventing the wheel, fixing the same issues repeatedly, and relying on tribal knowledge that disappears when key employees leave. Clear, concise, and well-structured documentation turns complex processes into repeatable playbooks, empowering teams to work smarter, not harder. It bridges the gap between technical experts and business stakeholders, ensuring that knowledge is accessible, actionable, and aligned with company goals. Great documentation isn’t just about capturing “how” something works—it should also explain “why” decisions were made, preventing future teams from making the same mistakes. If your documentation isn’t easy to find, well-organized, and frequently updated, it’s almost as bad as not having any at all. The best documentation is written with the user in mind: Can a new hire follow it without asking for help? Can a non-technical person understand the key takeaways? Investing in documentation today saves countless hours tomorrow. It’s one of the highest ROI activities a RevOps team can prioritize.