Tridion for medical devices
Create documentation that is accurate, consistent and compliant
Whether you’re creating an IFU or reporting to a regulator, you need to provide accurate, clear and consistent information.
A structured content approach makes this simple – by organizing all your technical information centrally, using predefined modules and relationships.
It allows medical device companies to create, manage and distribute multilingual technical documentation at scale, much more safely and efficiently, in compliance with regulations such as EU MDR and IVDR, while being prepared for future changes, including new regulations and data-driven submissions.
Why Tridion?
Ensure productivity, compliance and shorter time to market for medical devices
Shorter time to market
Full traceability and auditability
Streamlined translation and localization
Omnichannel publishing
Seamless integration with your eQMS
Discover how to streamline your medical device global content supply chain
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Areas of expertise
Medical writing
Create up-to-date and compliant medical device-related content using structured content. Enable medical writers and reviewers to update content for any output quickly with omnichannel publishing, be it regulatory or commercial, while using clear content labels to ensure all claims made are consistent with the approved ones.
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Regulatory submissions
Increase productivity, ensure traceability and successfully meet regulatory compliance demands with an end-to-end documentation solution that enables structured content authoring and concurrent online collaboration with regulatory bodies and agencies for faster approvals.
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Key insights into the latest MDR requirements and how they seem to be aligning with the complex pharma regulatory ecosystem
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Solutions
Component content management
Create accurate, consistent, and always up-to-date content to comply with regulations and ensure patient safety. With modular and rules-based content you can achieve a 30-60% cost reduction through content reuse, since updated source content will automatically cascade throughout your medical technical documentation.
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Collective authoring and reviewing
Simplify the authoring and review process by using a web-based authoring tool that is as easy to use as Microsoft Word, without the hassle of desktop software. Replace the old-fashioned paper- or PDF-based way of reviewing content with a web-based tool that enables multiple internal and external reviewers to add comments concurrently to the same content, with a full audit trail.
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Integrated translation management
Realize 40-60% cost reductions by connecting to RWS translation management and machine translation. The integration creates a seamless and secure translation process for all your content, from product development documentation to promotional marketing collateral, enabling you to launch medical devices faster.
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Omnichannel delivery
Reduce up to 100% of time spent on recreating the same content for different outputs by reusing and repurposing the content you already have. Approved content chunks can be used across all documentation types, or any commercial channel needed – be it print, websites, chatbots, VR interfaces, or voice-controlled devices.
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Platform integration and dynamic content
Import data from external sources into specific content components and automatically update product manufacturing specifications or clinical trial files in real time. Integrate with your eQMS to achieve seamless information flow and faster approvals with significantly less time spent manually editing and publishing.
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