Create compliant regulatory submissions for medical devices and IVDs
Efficient. Accurate. Traceable.
Collate technical documentation at warp speed with cloud-based structured content authoring. By taking a content-centric approach to your submissions, you can collaborate seamlessly between internal stakeholders and external regulatory agencies to produce complete, compliant and up-to-date documentation.
Structured content is the foundation for centralized, automated regulatory submission processes. It breaks your content down into reusable components, so your teams can create multiple documents at the same time using the latest approved technical information – and update them just as easily.
Intelligent content for medical technical files
Use componentized content to create accurate, organized files for submission – and keep track of your edits every step of the way. With our structured content authoring tools, you can write, review, approve, translate, and maintain up-to-date documentation.
Create consistent, high-quality, on-time regulatory submissions with Tridion Docs
Download infographic
Five reasons to use structured content for your regulatory submissions
Successful market approval with compliant documentation
Allow authors to focus solely on creating and assembling high-quality content while automatically applying formatting and style guides in the publishing phase. With componentized content, document owners can easily create and update shared templates, that empower authors to publish in any format, at any time.
Augmented transparency and traceability
Understand at a glance which sections of your content have been approved and when, with closed-loop traceability throughout the device’s lifecycle – from development to post-market activities. Use clear content labelling to show authors and reviewers which components contain critical data or safety-related warnings.
Streamlined online collaboration for faster time-to-market
Offer internal and external teams a reliable, user-friendly and truly end-to-end digital authoring and reviewing solution. Stakeholders can find information faster by auto-tagging content and can create multilingual documentation more easily with integrated translation management.
Consistent and compliant documentation with automated change propagation
Eliminate content inconsistencies by reusing approved content. Working from a single source of truth, authors simply build content using format-free content components. Granular changes at the source automatically trigger updates throughout the technical file to ensure accuracy across all documents.
Seamless integration with your eQMS
Streamline your entire regulatory submission process by connecting all the pieces of your content puzzle. Our structured content management solution operates seamlessly with any existing eQMS, RIM, or EDC software. Your teams can now integrate content into cross-departmental workflows, without worrying about losing or duplicating data.
Increase product safety and traceability from design concept to post-market activities
Streamlined connected collaboration
Compatible with your eQMS
Content and translation reuse
100% reliable audit trail
Omnichannel publishing
Discover how our clients write and publish content faster with Tridion Docs
Want to explore how to optimize your regulatory submission processes?
Contact us