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.

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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.

Achieve regulatory compliance with a data-centric approach

The introduction of the Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) represents one of the greatest shifts in regulatory requirements for medical and diagnostic device manufacturers in recent history, increasing the burden of creating technical documentation faster within budget constraints, often stifling innovation.

Download our comprehensive whitepaper and read about the solution we propose for the challenges the MedTech industry is facing.

Understand how you can overcome these bottlenecks and create consistent, complete, and traceable technical documentation with the help of granular content and content reuse.

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Create consistent, high-quality, on-time regulatory submissions with Tridion Docs

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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

“RWS helped us understand the paradigm shift required to move to this new environment. We particularly appreciated that they were committed to helping us configure the system to meet our needs rather than forcing us to adopt a particular, pre-defined method of use.”

Josh Steen – Principal Technical Writer and Tools Specialist – Waters Corporation

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“With Tridion Docs in place, we can look to the future, to re-using content for educational purposes.”

Stef Mestrom – Project Manager Image Guided Therapy – Philips

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“We realized we had to put a strategic plan in place. We could no longer live with the traditional methods of documentation and needed to have repeatable, scalable processes that would enable us to support the business growth.”

Jean Michel Guillot – Documentation Manager – Horiba Medical

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“In bringing our products to a global market, we faced the challenge of developing high quality technical documents. RWS has a mature set of content management solutions, and has a localized deployment and technical support team.”

Guan Lei – Technical Communication Center – United Imaging Healthcare

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Resources

Structured content authoring

A web-based solution with an intuitive Word-like interface that transforms content creation for authors, subject-matter experts and other content stakeholders in life sciences, financial services, manufacturing and other industries.

Structured content authoring and semantic AI

From filing cabinets to cloud-based data storage and management apps, documents have seen a shift from traditional formats towards semantically tagged information – shared in an open digital format.

A life sciences and financial services perspective on content

Explore use cases from industries that have a history in structured content – such as publishing and technical documentation – as well as industries that are newer to the game, including pharmaceuticals and financial services.

Convergence — Where Medical Device Regulations Meet Pharma

RWS 2022 European Medical Device Industry Report

See how the latest changes to Regulation (EU) 2017/745 (MDR) influence documentation requirements. In our latest European Medical Device Industry Report, you’ll discover how new linguistic requirements affect market prospects and how a centralized content solution simplifies compliance.

Want to explore how to optimize your regulatory submission processes?

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