Based on this experience, we have built a groundbreaking proprietary technology solution, CAPTIS™, to streamline MDR & IVDR document creation.
With thorough knowledge of all aspects of Medical Writing, we offer an unparalleled end-to-end solution to ensure that you stay on track with post-market surveillance documentation.
The CAPTIS™ solution can allow your team to streamline all aspects of your PMS documentation and avoid constant revisions. This not only improves efficiency and quality of medical writing teams, but also allows your RA project manager to quickly understand project status throughout the entire process.
Systematic Literature Reviews Simplified
CAPTIS™ allows you and your team to simplify and expedite systemic literature reviews like never before. Harnessing the power of machine learning and bolstered by decades of systemic literature review experience CAPTIS™ gives you the tools you need to create compliant IVDR & MDR documentation quickly and efficiently.
Source Document Management
Information consistently represented across your PMS related reports;
Simplified review process for Notified Bodies.
Literature Search Database Integration
Highly efficient literature reviews and reduction of manual effort with Literature Search Database integration and simple article management.
Adverse Event Databases Integration
Integrated with TPLC, Maude and other adverse event databases for higher efficiency in adverse event analysis, especially when volume of data is high.
Document Lifecycle Management
Reduced rework and resource burden for ongoing maintenance activities of CERs, PMCF reports, PMSRs, etc.
Maintain consistency across documentation by using predefined templates with relevant data required for your final reports.
Keep projects on track and ensure that the right information is shared at the right time among project managers, writers, and subject matter experts.
Verbiage tied to specific words or phrases can be added to a master dictionary for easy re-use and consistency increasing speed and consistency in report writing.
Article Audit Trails
Full traceability of reviews and analysis conducted to support NB audits.
Mirroring sections in Document Creation
Sections or text that should remain consistent across different documentation gets mirrored to give you consistency across documentation.
Bulk Import of Search Data
Cut time spent on collating data with bulk imports of search data.
Customizable Data Collection Forms
Automatically updated summary tables thereby reducing human error
Automatic Full-Text Retrieval
Automatic retrieval of full-text articles saves time for medical writers.
Why Choose CAPTIS™?
|Improved data retrieval due to Google Scholar and Europe PMC integration||✓||✕||
|Option for separate but intertwined SoTA (State-of-the-Art) & DuE (Device under Evaluation) workflows||✓||✕||
|Customizable tables for summary reports||✓||✕||
|Source document management||✓||✕||
|Audit trail & reproducibility||✓||✕||
|US FDA MAUDE/TPLC adverse event database integration||✓||✕||
|In-built writing support||✓||✕||
CAPTIS™ helps our team write the highest quality PMS documentation, faster.
Redefining Compliance for EU MDR & IVDR
Maximize the Efficiency of your Medical Writing Team with CAPTIS™
Whether internal or external, your medical writing team can benefit from CAPTIS™ with faster turnaround times for systematic literature reviews and end-to-end MDR/IVDR documentation support.