Tridion Docs for medical devices
Structured content for medical
device manufacturers to ensure
productivity, compliance andshorter time to market

Tridion Docs for medical devices

Your medical device documentation:accurate, consistent and compliant
Creating and distributing technical medical documentation at scale can quickly become
an unmanageable task. The information you provide for your medical products – whether
it’s via marketing materials, labels, instructions, clinical evaluations or regulatory
reports – needs to be highly detailed, accurate and easy to access. And what’s more,this documentation must be consistent across all languages, channels and devices.

The challenge: A document-centric approach
Authoring a document like a regulatory submission or IFU, circulating a draft forreview and manually consolidating all the stakeholder comments before sending it fortranslation is no longer the most efficient approach.
Medical professionals, patients and researchers must have quick and easy access to themost up-to-date information about how to use the device. And auditors and regulatorsneed a full view of your documentation to ensure compliance and process regulatory
submissions efficiently.
For medical device documentation to be truly useful and accessible, the production
process must be faster, more flexible and have the ability to scale in a cost- andtime-effective way.

The solution: a structured content approach
To offer your employees a more agile, iterative way of creating documentationand ensure users can access the information they’re looking for,you need to start by redefining your content supply chain.
With Tridion Docs, you can centralize the creation,translation and delivery of all your content types.
It helps you organize all your information ina structured way, using predefined modules
and relationships to build your content froma single source of truth.
Tridion Docs allows you to easily reuse, share,
filter and deliver any piece of multilingual
content – from a single paragraph toa 1,000-page document – to any channel.

2 | Tridion Docs

A single source of truth
for your medical device
information accelerates
your global content
supply chain

Tridion Docs for medical devices

With Tridion Docs, you can create,
manage and deliver in-depth
information about your devices
at scale using a structured
content approach
The content you produce for your devices will likely
overlap in multiple channels, which raises a major
challenge. The information needs to be consistentand up to date in every touchpoint but, if you don’t
have the right processes in place, this can lead toextensive reworking – especially if your content isavailable in multiple languages.

Tridion Docs is a DITA-based component
content management system, which storesand organizes information about your devices
as topics. This approach allows you to reducethe volume of source content while ensuring
each of your channels are served with highly
detailed documentation.
With its scalability, simplicity and automation
capabilities, Tridion Docs helps you manage
your content library with accuracy, efficiency andgovernance at the forefront. It’s a collaborative
system, which means multiple teams can work
side-by-side to plan, create and review
documentation in a highly agile way.

Structured authoring allows you to build content withreusable modules – or components – which can be
repurposed in multiple publications. And enabling
reuse early in the process maximizes the benefits.
For example, a description for a component in a
CT scanner written during the development process
could be reused later in a service manual. Or, input
from a clinical evaluation report could feed into aregulatory submission to provide further detail about
a continuous glucose monitor. In both cases, reuse
would help ensure consistency and save time andeffort ahead of the device’s launch.

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Structured content leads
to shorter development
timelines and can reducetranslation and publishingcosts by as much as 50%

Tridion Docs for medical devices

How Tridion Docs transformsyour content processes
Streamline your content operating model and remove the bottlenecks with Tridion Docs’market-leading capabilities in every phase of the production process.

Create and manage

Collaborate and review•

Centralized structured
content authoring•

Easy authoring for SMEs•

Content reuse•Streamlined workflows•

Publication and baseline management•

Cross-team collaboration•

Conditional text•

Compliance and auditabilityYour authors can use their preferred
tools, from complex XML editors
to simple browser-based word
processors. They don’t need to beXML experts, as Tridion Docs manages
the underlying structure in thebackground while they author
and review documents.
•

Dynamically assembledeliverables in any output format
from a single source, whether
it’s a PDF user manual or aregulatory submission

Subject matter experts are a criticalpart of the content creation process,applying their knowledge to ensureeach device is accompanied by therelevant medical information, technicalinput and regulatory requirements.
To empower this collaboration,
Tridion Docs offers:•

Collective Spaces, an online
environment that allows authors
to collaborate in real time, with noneed for cumbersome PDF markup•Baseline Manager grants you
rigorous control over every version
of a document, helping you map
dependencies between yourcontent and ensure accuracy•Review overlays that allow
multiple stakeholders to provide
feedback on the same document
simultaneously, consolidating their
input from the first instance•Condition Manager offers further
precise control over conditional
text within the document variants
you produce for different device
models, markets or applications•Threaded conversations to keep
feedback discussions focused andin a single channel

4 | Tridion DocsTridion Docs for medical devices

Translate and localize

Comply and report•

Integrated translation
management•

Simple, componentized
regulatory submissions•

Translation reuse•

Full traceability•

Translation reporting•

Secure access for auditors•

Multilingual publication
management•

Data integration for reporting

Translations are a critical, but often
costly, part of the content delivery
process. And when you’re supplying
medical equipment to multiple
markets, there’s no room
for mistranslation.
With Tridion Docs, you can managetranslations directly from theplatform with:
Multilingual controls to manage
publications with more thanone language and reuse
existing translations
Translation management system
integration that allows content to besubmitted directly from Tridion Docs
Templated output for multilingual
content to eliminate expensive
desktop publishing

5 | Tridion Docs

Regulatory submissions are aconsistent bottleneck for medical
device manufacturers, as even thesmallest inconsistency can lead toa rejection. Tridion Docs creates anenvironment where compliance isbuilt into the content authoringprocess, with:
Submission templates which flowin content automatically, ensuringconsistency and correct formatting
Change logs that record all changes
to a document for full traceability
and auditability
Secure access which allows
regulators to provide feedback
as easily as internal teams toaccelerate complianceTridion Docs for medical devices

Deliver and distribute•Single-source content delivery•

Content variations•

Omnichannel publishing•

Contextual delivery

As well as traditional content formats such as PDF, Tridion Docs can support
content on any channel and device, with:•Dynamic Documentation, a fully responsive, out-of-the-box
digital documentation portal•

Headless content APIs that can deliver personalized
content to any digital touchpoint•Simple scalability to support digital content
distribution on a global scale

6 | Tridion Docs

Tridion Docs for medical devices

Discover the quantitative benefitsof Tridion Docs

Tridion Docs

100%

30–50%

reduction in desktop
publishing costs

82%

of clients saw an ROI
in Tridion Docs in
18–24 months
or less

7 | Tridion Docs20%

reduction in content
development andlocalization
costs

reduction intranslation costs

50%

increase inefficiency ona yearly basis

Tridion Docs for Medical Devices

Discover how you can streamline your global
medical writing processes with Tridion Docs
Learn more attridion.com/medical-devices

About RWS
RWS Holdings plc is a unique, world-leading provider of technology-enabled language, content and intellectual property services.
Through content transformation and multilingual data analysis, our combination of AI-enabled technology and human expertise helps
our clients to grow by ensuring they are understood anywhere, in any language.
Our purpose is unlocking global understanding. By combining cultural understanding, client understanding and technical understanding,our services and technology assist our clients to acquire and retain customers, deliver engaging user experiences, maintain complianceand gain actionable insights into their data and content.
Over the past 20 years we’ve been evolving our own AI solutions as well as helping clients to explore, build and use multilingual AI
applications. With 45+ AI-related patents and more than 100 peer-reviewed papers, we have the experience and expertise to supportclients on their AI journey.
We work with over 80% of the world’s top 100 brands, more than three-quarters of Fortune’s 20 ‘Most Admired Companies’ and almost
all of the top pharmaceutical companies, investment banks, law firms and patent filers. Our client base spans Europe, Asia Pacific, Africa
and North and South America. Our 65+ global locations across five continents service clients in the automotive, chemical, financial, legal,medical, pharmaceutical, technology and telecommunications sectors.
Founded in 1958, RWS is headquartered in the UK and publicly listed on AIM, the London Stock Exchange regulated market (RWS.L).
For further information, please visit: www.rws.com© 2024 All rights reserved. Information contained herein is deemed confidential and the proprietary information of RWS Group*.
*RWS Group shall mean RWS Holdings plc for and on behalf of its affiliates and subsidiaries.

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