Technology for EU MDR Compliance
The Celegence team has extensive experience writing EU MDR compliant documentation including Clinical Evaluation Plans & Reports and Post Market Surveillance Reports.
Based on this experience, we have built a groundbreaking proprietary technology solution, CAPTIS, to streamline MDR 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.
Meet CAPTIS – Your New EU MDR Compliance Tool
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Key CAPTIS Features
- Source documentation management so that information is consistently represented across your PMS related reports
- Literature Search Database integration and simple article management
- Integration with TPLC, MAUDE, and other adverse event databases
- Document lifecycle management for maintenance of CERs, PMCF reports, PMSRs, etc.
- Predefined templates with relevant data required for your final reports
- Collaboration among project managers, writers, and subject matter experts
Key CAPTIS Accomplishments
- Hundreds of post-market surveillance reports created
- Thousands of hours saved in medical writing activities, reducing costs and resource burden significantly
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.”
“CAPTIS is a very innovative and time saving platform and makes the CER writing process quick and convenient.”
“A majority of our manual processes are now automated with the help of CAPTIS.”
CAPTIS helps our team write the highest quality PMS documentation, faster.
Compliance
- 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
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
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
Are Your Regulatory Resources Equipped for the MDR?
If you want to learn more how our technology solution can help your organization reduce its resource burden to comply with EU MDR, sign up below for a detailed demonstration from our solutions team!
