A chat with a medical device manufacturer: scaling regulated documentation without scaling risk

What does it take to ship regulated documentation like a release-ready system, not a last-minute scramble. In this conversation with RWS Solutions Architect and Strategist, Dipo Ajose-Coker, a global medical device manufacturer shares how Tridion Docs helped them regain control across products, variants, manual types, and languages, with fewer fragile handoffs and less downstream rework. We also look ahead to what they want next, for example, tying product documentation into their enterprise AI initiative so future automation is grounded in governed, current content.

Deliver everything, everywhere, all at once.

• Global medical device manufacturer, Ultrasound division

• 20 technical writers, 30–40 reviewers, multiple products, multiple regulatory regions, hundreds of documents, 36 languages

• Multiple products and variants, including human and veterinary use cases, plus regional requirements such as China-specific content

• FDA, EU MDR, NMPA, and third-party certification bodies such as Intertek  

Starting point

• Legacy SGML-based content management, heavy manual publishing in FrameMaker

• RWS Tridion Docs with structured authoring, reuse, controlled variation, and integrated localization with RWS TMS and RWS translation services.

• Documentation aligned to a phase-gate milestone with synchronized global availability for the first time

Turning documentation into a release-ready system

Section	Summary
Challenges	Documentation supported multiple products and variants, each requiring multiple manual types (operator, service, installation, and more) Legacy SGML-based workflows made consistency, reuse, coordinated updates, review, translation, and publishing difficult to sustain at scale Manual publishing and review processes increased effort as product scope expanded Staggered language releases creating version drift risk and coordination overhead Limited administrative capacity to support growing documentation and regulatory demands as complexity grew
Solution	RWS Tridion Docs for structured, topic-based authoring, reuse, and controlled variation Conditionalization to manage differences across products, variants (including veterinary), and regional requirements (including China-specific content) Integrated workflows connecting authoring, review, publishing, and localization into one system Automated publishing to generate multiple manual types from shared source content Localization integrated via RWS TMS and RWS translation services as an embedded lifecycle capability
Results	Documentation aligned to a phase-gate milestone for a major platform release, enabling synchronized global availability for the first time ever Release timelines accelerated by [placeholder: X months] compared to previous cycles Reduced manual effort across authoring, update, review, publishing, and localization activities [placeholder: qualitative improvement, no formal metrics tracked] Improved consistency across manual types and variants through centralized updates and reuse Reduced operational risk associated with duplicated content, staggered releases, and late-stage corrections
Next steps	Expand reviewer participation using Collective Spaces (Review Space and Draft Space) Improve review traceability and reporting to support verification and validation evidence Establish clearer branching and versioning practices for parallel product and manual updates Explore AI-assisted verification and quality checks built on trusted structured content

Area	Before: legacy SGML + FrameMaker workflow	After: Tridion Docs release-ready system
Documentation scope	Separate documents maintained independently for each product, variant, and manual type	Structured content supports multiple products, variants, and manual types from a shared content base
Content creation	English content authored and managed at the document level	Topics authored once and reused across manuals, products, and variants
Manual types	Operator, service, installation, and variant-specific manuals created and updated separately	Multiple manual types generated from the same structured source content
Product variants	Variant-specific manuals maintained as separate document sets	Conditionalized content supports variants such as human and veterinary use cases within one controlled structure
Updates and changes	Changes applied manually to each affected document and manual type	Changes made once and automatically reflected across all relevant manuals and variants
Review and coordination	Reviews managed through PDFs and external logs, increasing coordination effort	Reviews coordinated within the documentation system, supporting consistency and traceability
Publishing	Manual publishing repeated for each manual type, variant, and language	Repeatable publishing generates all required manuals in a consistent, controlled way
Localization workflow	Manual file exchange per language, with post-translation rebuilding and fixes	Localization integrated via RWS TMS and RWS translation services, reducing manual handling and supporting coordinated release readiness
Multilingual delivery	Language handling treated as a downstream process	Multilingual delivery integrated into the same documentation lifecycle
Scalability	Effort increases linearly with each new product, variant, or manual	Documentation scales through reuse, structure, and controlled variation
Release cadence	Manuals released in stages, increasing coordination and version drift risk	Documentation aligned to a single phase-gate milestone across products, variants, and manual types
Operational risk	High risk of inconsistency, delay, and late-stage corrections	Reduced risk through centralized control, reuse, and release alignment

When documentation spans multiple products and manual types, manual workflows do not scale. This comparison shows how Tridion Docs turns documentation into a controlled, release-ready system.

If you build complex medical devices, you already know the rule: documentation does not get to be “mostly right.” It must be right, everywhere, every time, and in every language you ship.

Documentation in this ultrasound division operates at enterprise scale. Multiple product variants are developed in parallel, each with its own regulatory, regional, and audience-specific requirements. Large, multi-volume manuals are produced for global distribution, delivered in 36 languages by a team of roughly 20 technical writers, supported by 30–40 reviewers, and subject to strict review and verification expectations. Content is reused across products, adapted for regional needs such as China-specific requirements, and maintained over successive releases. In this context, documentation is not a static deliverable. It is a living system that must hold up under constant change.

And the regulatory landscape is not forgiving. The team must satisfy FDA expectations, align with EU MDR requirements, support NMPA-driven needs, and be audit-ready with organizations like Intertek in the mix.

The documentation lead we interviewed sits in the middle of all of it: publication output, translation coordination, and day-to-day administration of the documentation platform. In their words, the job grew as headcount shrank. “We went down to two people… it’s a little much for just me with my other roles.”

That is the backdrop. Now add the old operating model.

Before RWS Tridion Docs, the team relied on a legacy SGML-based environment and a manual, error-prone publishing chain.

One pressure point made the problem impossible to ignore: the workflow could not support coordinated global release across products, variants, manual types, and languages without multiplying manual effort. What had once been an acceptable workflow could no longer absorb the volume, variation, and pace the business demanded.

The previous workflow looked like this:

• Create SGML from English content
• Send SGML out for translation
• Receive a translated SGML file per language
• Build a translated FrameMaker file from each SGML file
• Fix errors in each translated FrameMaker file
• Generate massive PDFs (often running into the thousands of pages)
• Repeat, across languages

The documentation lead described it plainly: “It was a long process.”

Then came the part nobody misses, linguistic sign-off edits arriving in marked-up PDFs, followed by painstaking manual updates in translated files. “Looking at Chinese characters and Russian… painstakingly edited the translated manuals.”

Content reuse was also breaking down. By the time the documentation lead joined, the legacy system “wasn’t really working for reuse anymore,” so teams drifted into duplication. That created predictable risks: version drift, inconsistent updates, and needless rework every time “standard” content needed a change.

Review workflows did not help. Reviews were managed by sending PDFs, collecting comments by email, and maintaining a review log (often an Excel-based process). The team still had to catalogue and verify reviews for release evidence, but the mechanics were fragmented.

Put it together and you get a familiar pattern in regulated industries:

• The content is critical
• The process is fragile
• The workload grows
• The timelines do not move

Reuse became enforceable, not aspirational

Publishing became repeatable at scale

Localization moved from manual handling to an integrated flow

The team did not claim perfect metrics yet. They have not had the capacity to formalize time or cost savings tracking, and they want better reporting to support that.

But the outcomes are still clear, and they show up in the moments that count.

Delivering documentation at scale is not just about speed. It is about coordination. When content spans multiple products, regions, and regulatory contexts, timing matters as much as accuracy. Releasing documentation in waves introduces friction, rework, and risk. Aligning everything to a single milestone changes how the organization operates. It turns documentation into a dependable part of the release process, rather than a trailing activity.

All languages, at the product-release milestone, for the first time

Improved quality through consistency

Audit readiness with fewer documentation-related incidents

The next phase is about tightening the governance layer, not just speeding up output.

Collective Spaces for reviewer accountability and evidence

Branching and merging best practices

AI and content verification, grounded in compliance reality

• Builds reuse across products, variants, and manual types so critical updates do not drift
• Generates multiple manuals from shared structured content instead of duplicating documents
• Moves toward in-system review traceability that supports verification evidence
• Integrates localization workflows so language availability supports release readiness, rather than dictating it