Compliance in Technical Writing

Users don't suck, but the information provided to them can. If your IFU reads like a legal contract, people won’t read it. Why? Because they’re confusing. Too wordy. Too complex. Too scattered. A great IFU should feel like having a clear-headed expert guiding you step by step. The user needs to know what to do, how to do it, and when to do it. Here's 20 recommendations/writing rules to improve your IFU↴ 1. Write procedures in short, identifiable steps, and in the correct order. 2. Before listing steps, tell the reader how many steps are in the procedure. 3. Limit each step to no more than three logically connected actions. 4. Make instructions for each action clear and definite. 5. Tell the user what to expect from an action. 6. Discuss common use errors and provide information to prevent and correct them. 7. Each step should fit on one page. 8. Avoid referring the user to another place in the manual (no cross-referencing). 9. Use as few words as possible to present an idea or describe an action. 10. Use no more than one clause in a sentence. 11. Write in a natural, conversational way. Avoid overly formal language. 12. Express ideas of similar content in similar form. 13. Users should be able to read instructions aloud easily. Avoid unnecessary parentheses. 14. Use the same term consistently for devices and their parts. 15. Use specific terms instead of vague descriptions. 16. Use active verbs rather than passive voice. 17. Use action verbs instead of nouns formed from verbs. 18. Avoid abbreviations or acronyms unless necessary. Define them when first used and stay consistent. 19. Use lay language instead of technical jargon, especially for medical devices intended for laypersons. 20. Define technical terms the first time they appear and keep definitions simple. Prioritize the user while ensuring MDR/IVDR compliance.

𝗜𝗘𝗖 𝟲𝟮𝟰𝟰𝟯 𝗶𝘀 𝗻𝗼𝘁 𝗷𝘂𝘀𝘁 𝗮 𝘀𝗲𝗿𝗶𝗲𝘀 — 𝗶𝘁’𝘀 𝗮 𝗳𝗮𝗺𝗶𝗹𝘆 𝗼𝗳 𝗱𝗶𝗳𝗳𝗲𝗿𝗲𝗻𝘁 𝗱𝗼𝗰𝘂𝗺𝗲𝗻𝘁 𝘁𝘆𝗽𝗲𝘀. 𝗔𝗻𝗱 𝗲𝗮𝗰𝗵 𝘀𝗲𝗿𝘃𝗲𝘀 𝗮 𝗽𝘂𝗿𝗽𝗼𝘀𝗲. When people say “IEC 62443 compliance,” they often miss an important nuance: not all documents in the series carry the same weight or intent. Understanding the document types helps teams interpret requirements correctly and avoid treating guidance as mandatory controls. 𝗧𝗵𝗲 𝗺𝗮𝗶𝗻 𝗱𝗼𝗰𝘂𝗺𝗲𝗻𝘁 𝘁𝘆𝗽𝗲𝘀 𝗶𝗻 𝗜𝗘𝗖 𝟲𝟮𝟰𝟰𝟯 • IS — International Standard The normative requirements. These define what must be met for compliance or certification. 👉 Example: technical and process requirements • TS — Technical Specification Detailed technical requirements or methods where full consensus may still be evolving. 👉 Often more implementation-focused • TR — Technical Report Informational guidance, background, or explanatory material. 👉 Helps interpretation but is not normative • PAS — Publicly Available Specification Early guidance published quickly to address emerging needs. 👉 May later evolve into TS or IS 𝗪𝗵𝘆 𝘁𝗵𝗶𝘀 𝗺𝗮𝘁𝘁𝗲𝗿𝘀 Many teams mistakenly treat every document as mandatory — which leads to confusion and unnecessary complexity. In reality: 👉 IS defines requirements 👉 TS provides technical depth 👉 TR explains context 👉 PAS captures emerging practices Knowing the difference helps you build a roadmap that is both compliant and practical. #IEC62443 #OTSecurity #IndustrialCybersecurity #ICS #CyberResilience #Standards #SecurityFramework #CriticalInfrastructure

MDR Annex II: Ultimate Guide for Organizing Your Technical Documentation Missing crucial regulatory strategies is like building a skyscraper out of paper. There will be a result, but it will not meet expectations. Here is one of my paper-skyscraper experiences: I underestimated how important it is to properly organize a Technical Documentation. Back then, my folders were chaotic—mixing risk management files, clinical data, and product descriptions without a clear structure. This is where Annex II of the EU MDR comes into play. It provides a clear structure for your technical documentation, breaking it into 6 key chapters. Here’s a breakdown of Annex II and how to use it effectively: 1. Device Description and Specification ↳ Define the device’s intended purpose and classification. ↳ Include key design features and technical characteristics. ↳ Think of this as your product’s “business card.” 2. Information to Be Supplied by the Manufacturer ↳ Includes all device labels for single-unit, sales, and transport packaging. ↳ Labels must be provided in the languages accepted by Member States. ↳ Instructions for use (IFU) must also comply with language requirements. 3. Design and Manufacturing Information ↳ Describe development and manufacturing processes ↳ Use flowcharts for clarity and simplicity. ↳ Show alignment between production and quality standards. 4. General Safety and Performance Requirements (GSPRs) ↳ Create a checklist linking evidence to Annex I requirements. ↳ Use a matrix to map compliance for each GSPR. ↳ Highlight key tests and documents supporting each claim. 5. Benefit-Risk Analysis and Risk Management ↳ Follow ISO 14971 principles for risk management. ↳ Show links between risks, mitigations, and residual risks. ↳ Document how benefit outweighs any residual risk. 6. Verification and Validation Data ↳ Provide clinical evaluations and performance testing results. ↳ Include usability studies to show real-world safety. ↳ Prove the device works as intended for its purpose. Why Follow Annex II? When a Technical Documentation is well-organized: → Auditors can quickly find what they need. → Your team works more efficiently during submission preparation. → Regulatory delays are minimized, and certification is faster. For my first project, I learned the hard way. Today, I always organize a Technical Documentation based on Annex II’s chapters—and it’s made all the difference. P.S. Are you organizing your Technical Documentation according to Annex II? Or do you follow a different structure? ---------------------------------- 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

One of the most slept on ways to break into cybersecurity is technical writing and I need more people to know about this. Companies are hiring for this right now and most people in career transition completely overlook it. But if you can write documentation you have a skill that is needed everywhere in this field. Let me explain what I mean. In the compliance and GRC space there is a constant need for people who can write and maintain security documentation. System Security Plans. Access Control Policies. Audit and Accountability Policies. Configuration Management Plans. Incident Response Plans. Contingency Plans. The list goes on. Every federal system needs these documents to exist and to be updated regularly. And a lot of programs either do not have them or have outdated versions sitting around collecting dust. That is where you come in. If you can learn how to write these documents and actually build them out you become valuable immediately. You do not need years of experience to do this. You need to understand the NIST controls, know what each document is supposed to cover, and be able to put it together in a way that satisfies the requirement. And here is the best part. You can start building this skill right now without being on the job. Pick a control family from NIST 800-53. Read what it is asking for. Write a policy around it. Do it for a fake system or a project you create yourself. Now you have something to show. That portfolio of work can get you in the door at a government contractor, a private company doing DOD work, or anywhere in between. Technical writers with cybersecurity knowledge are not easy to find and companies will pay well for people who actually know what they are doing. Do not sleep on this lane. It is wide open. #Cybersecurity #TechnicalWriting #GovTech

Quick tip to improve the technical writing in your NCs and CAPAs: Instead of relying on templates for each lifecycle phase, go one step further and create your company-specific best practice for populating each one and provide a few examples of what "good" looks like. For context: I was booked a few times this year to review CAPA procedures before upcoming ISO 13485 surveillance & recertification audits ... and this template thing is my "takeaway" in 2026 so far. An example I've seen: One of my clients (~300 employees, 8 sites worldwide) had this specific structure for how to formulate problem statements ↓↓↓ - Affected product - Count of affected products - SN, Article number, Lot Number - Where did the failure happen - Date when failure happened - Description of the failure (No examples for how it has to look filled out) While the points are all important, they introduce more questions than they answer. Just a few I had: • Do I need to fill all for process issues, too? • Do I write down the date the failure was identified or when the defect happened? • If the issue was identified externally, is this the relevant location, or where it was manufactured? And I'm certain your SMEs have many more questions, especially when it comes to containment and correction actions, or the investigation phase. One thing I've seen working well in preventing at least 50% of these questions is providing real examples, for both process and product NCs/CAPAs. (Ideally, you provide the additional information directly in the software, or in the work instruction/a best practise document. But don't put it in the procedure; it'll get too bloated, and people stop reading.) Additional information for "Where did the failure happen?" could be: - If identified externally, provide name of 3rd party and how it was identified - If identified internally, provide location where and how issue was identified and, if known, location where the issue was introduced A product example could be: ⤷ Affected product: Sterile single-use catheter, Art. No. 12-345 ⤷ Count of affected products: 12 of 480 units (Lot quantity) ⤷ SN / Article no. / Lot: No SN (lot-controlled), Art. 12-345, Lot 2025-11-0111 Where did the failure happen: Identified externally at distributor HealthSupply (Amsterdam) during incoming inspection. Introduced internally at sealing station 3, Site Hamburg. ⤷ Date when failure happened: Identified 14-Jan-2026. Sealing performed 08-Nov-2025. ⤷ Description of the failure: Visible channel in the sterile barrier seal on the pouch. 12 of 30 pouches failed dye penetration testing (per WI-QC-111), against an acceptance criterion of 0 failures. For the remaining 50% unanswered questions: Just ask Georg Digel 😁 Have a great week, y'all! PS: I have free resources to prevent these challenges on my homepage. Just click on "Visit my website" or in the featured section.

📝 Are you familiar with the intricacies of Clinical Evaluation Report (CER) writing in compliance with MDR requirements? As a seasoned regulatory professional, I understand the challenges that come with collecting, analyzing, and presenting clinical data effectively. In this post, I'll provide insights into the art of writing compelling CERs that meet regulatory standards. 1. Understand the MDR requirements: To write a successful CER, it's crucial to have a thorough understanding of the Medical Device Regulation (MDR) standards. This includes knowing the specific data and evidence required to support the safety and performance of your device. 2. Collecting clinical data: Gathering relevant clinical data is a key part of the CER writing process. This involves conducting comprehensive literature reviews, post-market surveillance, and post-market clinical follow-up studies to collect the necessary evidence to support your device's safety and performance. 3. Analyzing the data: Once the data is collected, it's important to analyze it effectively. This may involve statistical analysis, risk assessments, and a thorough evaluation of the clinical literature to demonstrate the safety and efficacy of your device. 4. Presenting the findings: Finally, presenting the clinical data in a clear and concise manner is essential for a successful CER. This includes creating a thorough and well-structured report that effectively communicates the safety and performance of your device to regulatory authorities. By mastering the art of CER writing, you can ensure that your medical device meets regulatory standards and gains approval for market entry. If you're looking to enhance your CER writing skills, I encourage you to join the conversation and share your insights. #MedicalDevices #RegulatoryCompliance #ClinicalData #MDRCompliance #CERWriting #MedicalDeviceRegulation 📝

🙈 𝗔𝗿𝗲 𝘆𝗼𝘂 𝗽𝗹𝗮𝘆𝗶𝗻𝗴 𝗵𝗶𝗱𝗲 𝗮𝗻𝗱 𝘀𝗲𝗲𝗸 𝘄𝗶𝘁𝗵𝗼𝘂𝘁 𝗿𝗲𝗮𝗹𝗶𝘀𝗶𝗻𝗴 𝘄𝗶𝘁𝗵 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘀 𝗱𝘂𝗿𝗶𝗻𝗴 𝘆𝗼𝘂𝗿 𝘁𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗳𝗶𝗹𝗲 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻? 😱 Ever submitted your medical device technical documentation without a compliance summary checklist? Including a compliance summary checklist alongside your documentation submission is like handing the assessors a treasure map. X marks the spot and they can swiftly find all the vital information, saving you from the dreaded round of "Where's Waldo" questions! 🗺️ While checklists aren't always mandatory, let's be real – they're a best practice. Your checklist guides the assessors to the information they seek without having to scroll through multiple documents. By doing so, you're not just complying with regulations but also winning the favour of those reviewing your submission. Trust me, they'll appreciate it more! Remember, a smoother submission process not only makes your life easier but also strikes a harmonious chord with the assessors. Happy assessors = impressed assessors! By including that compliance summary checklist, you're showcasing your dedication to clarity and transparency! #MedicalDevices #TechnicalDocumentation #Submission #EUMDR #510k