Technical Specification Documentation

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 )

Is Your Technical File Ready for Submission? When I first started working with MedTech founders, I noticed a common pattern: many treated the Technical File or Design Dossier as paperwork to complete before submission. The reality is that it can be much more than that. I worked with a medical device startup that rushed their Technical File, thinking it was simply a regulatory requirement. During their first audit, missing risk analysis and incomplete design verification caused delays and made investors question the readiness of the product. We took a step back, revisited the file, and organized it with purpose. Each section, from device description to labeling, risk management, and clinical evidence, clearly told the story of the product. - Verification and validation results were tied back to risk controls - Design decisions were explained with context - Traceability was clear and easy to follow As a result, the auditors understood the product quickly, and investors could see evidence of strong compliance and quality practices. A well-prepared Technical File shows that you understand your design, your risks, and your controls. It communicates that rigor to regulators, auditors, and investors. When you review yours, ask yourself: Is it simply paperwork, or is it showing the story of your product? How are you using your Technical File as a strategic asset? Below is a checklist that every Technical File should cover to tell the story of your product: #MedTech #FDACompliance #SaMD #HealthTechLeadership #Elexes #technicalfile

Some key documents required for a Product Manager in the hardware or robotics space. If your PM is not leading this or giving strategy for this in your startup, your PM needs to level up. It is one way traditional PM in software space is different from hardware space. 1) Market Requirements Document (MRD) The MRD defines the market needs, customer pain points, and business opportunities. Even before setting out to build product atall, this is needed to validate the opportunity. 2) Product Requirements Document (PRD) The PRD describes how the product should be built to meet those customer needs in the MRD. That is why the MRD should be written first 3) Product Specification Provides detailed technical requirements for engineers to build the product targeted at engineers. It will contain details like hardware block diagrams, key electrical components, hardware performance requirements (battery life required, sleep/wake times, sensor accuracy, data transfer speeds required, etc.), testing requirements (desired environmental and reliability specs, IP-ratings, etc.) etc. This is where you’ll describe in gory detail the technical requirements of your product. This is ideally supposed to be prepared by engineering manager with input from Product Manager We have other documents also that will be needed like Compliance & Regulatory Documentation, the Product Roadmap, Prototyping & Testing Reports etc. Because of the technical knowledge to be able to understand and interpret the hardware documents, you will often find engineering leaders actually becoming the hardware PM or transitioning to this role because of domains knowledge required. It could be learnt though, but it does takes time to know how to understand system architecture, block diagrams and be able to contribute to them without domain knowledge in the field. #robotics #hardwareproductmanagement #productmanagement

How long?! Yep, I know I don't look it, however as a founder in software development with 20 years under my belt, I've seen countless projects succeed and, sadly, some go south. One common thread in the successes, without a shadow of a doubt, is a meticulously crafted Software Requirements Specification (SRS). It's not just another document; it’s the blueprint for software project success. Did you know that without a proper SRS, your software project has a 70% higher chance of failure? That's a staggering figure, and it highlights just how crucial this document is. An SRS bridges the gap between business needs and technical implementation. It defines exactly what your software should do, how it should perform, and any constraints it must work within. It ensures everyone – from stakeholders defining business needs to developers writing code – is on the same page. Here at Full Metal, we know that an SRS provides crystal clear understanding, leads to realistic timelines and budgets, and drastically reduces costly rework. It’s about getting it right from the start, avoiding those moments where things have gone a bit pear-shaped. We make sure our SRS documents cover everything from the introduction and scope, to overall descriptions, functional requirements, and non-functional requirements like performance and security. We also include visuals and diagrams to ensure clarity. Of course, there are common pitfalls to avoid. Vague language, missing requirements, and feature bloat (or "gold plating" as some call it) can throw a spanner in the works. Precise language and clear definitions are key. And we've produced a lovely infographic to showcase these concepts. Read on. What’s your experience? Has an SRS saved one of your projects from disaster, or have you learned the hard way without one? #SoftwareBlueprint #SRSSuccess #TechLeadership

Do you know the single biggest reason why most outsourced software development projects fail? Most software projects fail to meet the client expectations because the outsourced development team does not invest in this crucial stage of development and directly start writing code from a high level brief. A Software Specifications Document (SSD), also known as a Software Requirements Specification (SRS), is a comprehensive description of the intended purpose, functionality, and performance of a software system. It serves as a blueprint that guides the software development process and helps ensure that the final product meets the client's needs and expectations. The importance of an SSD cannot be overstated, and neglecting this stage can have severe consequences for a project. Here are some key reasons why an SSD is crucial: 1. Clarity and Understanding: An SSD provides a clear, detailed understanding of what the software should do. It helps the development team understand the functionality, features, and behavior of the software. Without it, the team might not have a clear picture of what they are building, leading to misinterpretations and mistakes. 2. Communication and Agreement: The SSD serves as a common language between all stakeholders, including clients, developers, project managers, testers, and users. It ensures everyone is on the same page about what the software should do and how it should do it. This reduces ambiguity and prevents disputes over what was originally agreed upon. 3. Project Planning and Management: An SSD aids in estimating the cost, time, and resources required for the project. It helps in project scheduling, risk management, and allocation of responsibilities. Without it, the project can become disorganized and prone to delays and cost overruns. 4. Quality Assurance: The SSD forms the basis for testing and validation. Testers use it to check if the software behaves as expected and meets the specified requirements. Without an SSD, ensuring the quality and reliability of the software becomes challenging. That is why #healthtech entrepreneurs prefer to work with Arkenea Inc for its robust development process that entails proper documentation throughout the lifecycle of the project.