Creating a Technical
Course Outline When you place a medical device on the market in Europe, you must compile a technical file or design dossier as part of CE marking requirements. Other markets globally also require a similar set of technical documentation to support market clearance. This course guides you step-by-step through how to put together technical documentation with the focus on European requirements and incorporation of the enhanced requirements as a result of the adoption of the new Medical Device Regulation. The course includes what evidence and level of detail you need to supply in order to demonstrate your product conforms to relevant safety and performance principles.
File / Design Dossier
We also show you how to use the STED (Summary Technical Documentation) format for technical files and design dossiers and how this can provide a baseline for global technical documentation convergence. By using this internationally recognised approach, you can ease the task of global regulators and thereby smooth the review process. Many companies find it reduces time to market and costs, so this course could be hugely valuable for your organisation – especially if you want a regulatory submission that is recognised across global key territories.