MDR IVDR Compliance Tool2023-07-18T10:49:58+00:00
CAPTIS - MDR IVDR Compliance Technology

Technology for EU MDR & IVDR Compliance

Increase compliance and produce higher quality PMS documentation, faster.

The Celegence team has extensive experience writing EU MDR & IVDR compliant documentation including Clinical Evaluation Plans & Reports and Post Market Surveillance Reports.

EU MDR Compliance Software CAPTIS

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.

CAPTIS - MDR Compliance - Celegence

What do CAPTIS™ users have to say?

“Literature search results are far more reproducible and auditable with CAPTIS™.”

“A lot of my time is saved by utilizing one platform to access multiple databases.”

“A majority of our manual processes are now automated with the help of CAPTIS™.”

CAPTIS™ At A Glance

Easily edit article details

Easily Collect Data from Literature

Easily document management

Simple Document Management and Final Report Creation

Full update tracking.

Full Audit Trail and Reproducibility

Easily embed diagrams

Automatically Generated Reports

See how you can benefit from CAPTIS™ today

CAPTIS™ Features

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.

Predefined Templates

Maintain consistency across documentation by using predefined templates with relevant data required for your final reports.

Collaboration Tools

Keep projects on track and ensure that the right information is shared at the right time among project managers, writers, and subject matter experts.

Data Dictionaries

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
  • Improved metadata + higher percentage of full text PDFs are retrieved by cross-checking against two databases (PubMed and Google Scholar)
Option for separate but intertwined SoTA (State-of-the-Art) & DuE (Device under Evaluation) workflows
  • Run literature searches specific to State-of-the-Art data
  • Seamlessly move articles between workflows
Customizable tables for summary reports
  • Add new data fields for your projects as report formats change and as your team received Notified Body feedback
Source document management
  • Ensures reports reflect accurate information from the latest internal documentation such as IFUs, device description, etc.
Audit trail & reproducibility
  • Ensures reports reflect accurate information from the latest internal documentation such as IFUs, device description, etc.
US FDA MAUDE/TPLC adverse event database integration
  • Consolidated results for multiple product codes
  • Improved interface allowing search by brand name
In-built writing support
  • Ability to share workload with our writing team seamlessly and NB/Device Manufacturer intelligence regularly incorporated

CAPTIS™ Benefits

CAPTIS™ helps our team write the highest quality PMS documentation, faster.

CAPTIS - EU MDR Compliance - Quality


  • Expand the compliance capabilities of your team by reducing time spent on manual activities
  • Ensure your process for literature search and adverse event data collection maximizes compliance and reduces risk of Notified Body observations
  • Ensure your CERs and other PMS documents are submitted on time for each and every device product, based on the risk classification
  • Ensure first-time compliance with faster turnaround times
CAPTIS - EU MDR Compliance - Productivity


  • Our team already saves over 20% of time on each CER with CAPTIS™, as it eases the process of data analysis from both source documents and external sources such as literature databases and adverse event databases
  • Time saving features such as highlights, data tagging, and automated reports
  • Paired with our expert services, our technology allows our team to work cohesively to guarantee timelines are met, reduce your cost and improve overall efficiency
  • Writers focus on analysis rather than manual and tedious tasks
CAPTIS - EU MDR Compliance - Quality


  • Assured completeness of your documentation as per regulatory requirements, which will be accepted by your Notified Body the first time around
  • Make sure you use the latest source documentation with version control and alerts to writers as documents or data feeds get updated
  • Ensure all the boxes are checked for your device’s compliance. CAPTIS™ will hasten your process without any sacrifice in quality


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.

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Not Ready for a Demo Just Yet?

Watch our latest webinar on CAPTIS Now!

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