Deliver fit-for-purpose documentation for medical devices faster
Consistent. Standardized. Easy to understand.
Every successful clinical trial or launch of a medical device starts with a team of outstanding medical writers. However, they're under increasing pressure to create commercial and regulatory content faster while maintaining strict quality standards – often with outdated content tools.
By adopting structured content and an integrated documentation platform, your medical writers can optimize the authoring and reviewing process, while data-driven authoring accelerates the creation of high-quality documentation.
Meet compliance and quality standards at speed
Familiar MS Word-like interface
Component-based authoring
AI-assisted content reuse
Collaborative review process
Multi-regional and multilingual publishing
Intelligent authoring for medical writers
Use a structured content approach and spend less time searching, replicating or correcting information in your medical documentation. Automate your content workflows and switch focus from manually checking content consistency to improving clinical data interpretation.
Learn how to streamline content operations to meet MDR linguistic requirements
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Five ways intelligent content helps medical writers create documentation faster
Reduced authoring times with an agile, structured content approach
Define granular content modules you can reuse across your technical file whenever you need to for new versions, new markets or product variants. Start with a clear medical device documentation structure and then populate it with new or pre-approved content components.
Consistent and accurate documentation with content templates and standards
Increase consistency by defining content templates and rules for constructing content modules and where they can be reused. Implement clear content rules and industry taxonomies to deliver compliant documentation faster and avoid change requests that aren't compliant with MDR or FDA requirements.
Faster reviews for clinical and regulatory content
Accelerate content review and revision with automated workflows that allow document owners to define review and approval paths for each content component. Make it easy for subject matter experts to see which piece of content needs their attention and approve it, make edits or leave comments.
Improved traceability of information across the medical device lifecycle
Create source content modules you can reuse in any medical communication output, from medical device development documentation to clinical trials or labels. Quickly identify where content has been reused, see who made which changes to which content module, and gain complete traceability of data sources.
Simplified publishing and reduced costs for multilingual product and safety information
Use translation memories to create and publish multilingual user manuals much faster and cheaper. Structured content accelerates and simplifies localization, as you only need to translate new or updated content modules before publishing your new documentation.
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