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MDR IVDR Compliance Tool2025-03-07T11:32:43+00:00

Trusted by the most innovative organizations

Celegence - Bausch Lomb - Life Science Regulations
EU MDR & IVDR Compliance - Argon Medical Devices
EU MDR & IVDR Compliance - Biotech Dental
EU MDR & IVDR Compliance - INION
EU MDR & IVDR Compliance - Medicept
EU MDR & IVDR Compliance - MicroPort
EU MDR & IVDR Compliance - Qapel

CAPTIS™ streamlines all MDR & IVDR document creation. The system can be used to create multiple types of reports more efficiently, including CERs, PERs, SSCPs, and PSURs.

The CAPTIS solution allows your team to write PMS documentation in much less time and avoid constant revisions. It not only improves efficiency and quality of medical writing teams, but also allows your project manager to quickly understand status throughout the entire project.

Designed to cater to the specific requirements of our global clients, including small, mid-sized, and large medical device manufacturers worldwide, CAPTIS exemplifies our commitment to providing innovation to increase quality and efficiency while reducing cost for the industry.

CAPTIS Modules

The 4 modules of CAPTIS include workflows to ensure your medical writing processes become more efficient:

Literature Review

Systematic Literature Reviews Simplified

CAPTIS™ allows you and your team to simplify and expedite systemic literature reviews with unparalleled efficiency. 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.

Adverse Events

Enhanced US FDA MAUDE and TPLC Integration

With direct integrations with US FDA MAUDE and TPLC, you can search for multiple product codes, device names and manufacturers in the same search. Never miss out any on device/manufacturer name variations! The Adverse Event Module also has Subject Device comparisons in TPLC reports (not available in TPLC) and no 500-record limit (unlike MAUDE).

Source Documents

Validated Central Repository for all Project Related Documentation

• Have all of your project documentation in one location with collaboration and commenting tools and version history support.
• Create bookmarks to save crucial information for later.

Report Writing

Enhanced PMS Report Creation experience

• Create unique template-based guidance systems for your team.
• For simpler content verification and traceability, link content from draft reports to technical documentation.
• Use the Data Dictionaries to maintain data repositories, and link sections to streamline common device data across multiple reports.
• Add auto-updated Literature Tables produced by the Literature Review module automatically added to the Report. Create unique Review workflows.

Literature Review

Systematic Literature Reviews Simplified

CAPTIS™ allows you and your team to simplify and expedite systemic literature reviews with unparalleled efficiency. 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.

Adverse Events

Enhanced US FDA MAUDE and TPLC Integration

With direct integrations with US FDA MAUDE and TPLC, you can search for multiple product codes, device names and manufacturers in the same search. Never miss out any on device/manufacturer name variations! The Adverse Event Module also has Subject Device comparisons in TPLC reports (not available in TPLC) and no 500-record limit (unlike MAUDE).

Source Documents

Validated Central Repository for all Project Related Documentation

• Have all of your project documentation in one location with collaboration and commenting tools and version history support.
• Create bookmarks to save crucial information for later.

Report Writing

Enhanced PMS Report Creation experience

• Create unique template-based guidance systems for your team.
• For simpler content verification and traceability, link content from draft reports to technical documentation.
• Use the Data Dictionaries to maintain data repositories, and link sections to streamline common device data across multiple reports.
• Add auto-updated Literature Tables produced by the Literature Review module automatically added to the Report. Create unique Review workflows.

See how CAPTIS can help you as a…

Medical Writer - CAPTIS Software Technology - Celegence

Medical Writer

  • Reduction of Manual Effort: Integrations with Literature Databases, automatic capture of all article metadata upon saving a search, dedicated State of the Art workflow, automatic duplicate detection and open-access PDF downloads, integration with FDA MAUDE and TPLC Databases etc.
  • Traceability: Audit trail of previous actions to ensure quicker Notified Body turnaround time
  • Quality & Consistency: Templates ensure information across documentation is presented consistently; easier abbreviation and reference management
Reviewers - CAPTIS Software Technology - Celegence

Reviewer

  • Cross-team collaboration: commenting, simultaneous review, and ability to add sequential review workflows
    More efficient content verification with source document linking
  • More efficient content verification with source document linking
Project Manager - CAPTIS Software Technology - Celegence

Manager

  • Project Visibility & Data Control: Regardless of how work is getting done, maintain ownership and access of project data including historical archives
  • Compliance: Update templates according to Notified Body feedback and benefit from Celegence’s expert team’s knowledge
  • Quality: Increase consistency across reports with data dictionary and templates
  • Easier Maintenance & Knowledge Management: Centralized repository with prior versions, history and audit trail maintained in the system; making the process less people-dependent

CAPTIS™ Features

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.

Here are the features CAPTIS has to offer:

Source Document Management

Source Document Management

Information consistently represented across your PMS related reports;
Simplified review process for Notified Bodies.

Literature Search Database Integration

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

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.

Article Audit Trails

Article Audit Trails

Full traceability of reviews and analysis conducted to support NB audits.

Predefined Templates

Predefined Templates

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

Document Lifecycle Management

Document Lifecycle Management

Reduced rework and resource burden for ongoing maintenance activities of CERs, PMCF reports, PMSRs, etc.

Data Dictionaries

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.

Collaboration Tools

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.

Bulk Import of Search Data

Bulk Import of Search Data

Cut time spent on collating data with bulk imports of search data.

Customizable Data Collection Forms

Customizable Data Collection Forms

Automatically updated summary tables thereby reducing human error

Mirroring sections in Document Creation

Mirroring sections in Document Creation

Sections or text that should remain consistent across different documentation gets mirrored to give you consistency across documentation.

Automatic Full-Text Retrieval

Automatic Full-Text Retrieval

Automatic retrieval of full-text articles saves time for medical writers.

CAPTIS Brochure

CAPTIS Brochure

Download the latest brochure about CAPTIS now.

Why Choose CAPTIS™?

FEATURE CAPTIS™ OTHER SOLUTIONS BENEFITS
Improved data retrieval via PubMed and Google Scholar ✓ ✕
  • 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 ✓ ✕
  • Audit trail to understand details of past decisions have been made and how data has been extracted from various databases
US FDA MAUDE/TPLC adverse event database integration ✓ ✕
  • Consolidated results for multiple product codes
  • See all device brand names reported on MAUDE; never miss out on a device name variation
Writing Support & In-Built Regulatory Intelligence ✓ ✕
  • Ability to share workload with our writing team seamlessly and NB/Device Manufacturer intelligence regularly incorporated
Content Linking when drafting Reports ✓ ✕
  • Seamlessly link content from the referenced Technical Documentation
  • One-click data verification for Reviewers
Plug Dynamic Literature Review Tables into Reports ✓ ✕
  • Easily plug literature tables generated from the Systematic Literature Review
  • Dynamic tables which update automatically based on any updates in the Literature Review
In-built writing support ✓ ✕
  • Cite included articles and Technical Documentation easily
  • Save cost; no need for additional Reference Management Software subscription
Subscription & Service Delivery Models

How can your team benefit from a CAPTIS™ subscription?

  • In-house: Your team completes all work in the CAPTIS platform; save time and reduce manual effort of your medical writers

  • Collaborative: Our team works with yours together in the CAPTIS platform; benefit from collaboration features and access to all project data

  • Outsourced: Celegence’s expert team completes all work in CAPTIS; you maintain ownership & access to all project data

CAPTIS™ News

Redefining Compliance for EU MDR & IVDR

CAPTIS Innovation Lab

Celegence’s Innovation Lab is a versatile team of experts, including data scientists, linguists, NLP engineers, software developers, subject-matter experts, product managers, and industry specialists.

Together, we are dedicated to the continuous evolution of CAPTIS, our cutting-edge software solution for the life sciences industry.

Testimonials

“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.”
Maximize the Efficiency of your Medical Writing Team with CAPTIS™

Fill in the form now to get a 1-on-1 demo of CAPTIS and see how you and your team can benefit from it.

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