Under EU MDR, all medical device manufacturers require advanced PMS systems, processes, and personnel to manage these requirements. A medical device Post-Market Surveillance system should provide consistent information for devices already on the market. It is the key function to maintain your product is functioning correctly and at the highest possible safety level for users. With our help, adverse events become more preventable, and clients’ PMS reports become far more manageable for their team.
Celegence provides global PMS guidance. We specialize in major markets like the EU and the United States but have worldwide partners with expertise relevant to your needs. Our customizable solutions allow you to utilize our templates that are in accordance with regulation as well as your Notified Body requirements.
60%
Time savings on Systematic Literature Reviews
30%
Faster Clinical Evaluation Report turnaround time
99%
First-time acceptance rate from Notified Bodies
10%
Cost savings on CERs
PMS Plan Design
Research, Including
Schedules for Follow-up Assessment Procedures
Data Collection and Statistical Analysis
Guidance on Notified Body Interactions
Interim and Final Data Analysis Requirements Guidance
Writing Services for
Understanding the regulatory framework that governs the PMS is the
first step towards effective compliance. Regulatory bodies across
the globe have set forth specific guidelines that dictate how
medical device manufacturers should monitor their devices after
their launch on the market.
Familiarity with these regulations is crucial for manufacturers to
not only adhere to legal requirements but also to maintain the
trust of healthcare providers and patients. The EU MDR and the
guidelines provided by entities like the FDA in the United States,
MDCG and IMDRF in Europe, and other international bodies outline
clear expectations for ongoing surveillance, reporting
requirements, and the necessary corrective action
Clinical Evaluation Reports (CER)
Systematic Literature Reviews (SLR)
MDR/IVDR Compliance Solution
CAPTIS®is a secure, user-friendly web-based application that assists medical writers with the laborious process of creating regulatory documentation for EU MDR/IVDR compliance such as CEP/CER, PEP/PER, SVR, PMCF Plan/Report, SSCPs and more.
Celegence team has extensive experience writing EU MDR & IVDR compliant documentation. Based on this experience, we have built a groundbreaking proprietary technology solution, CAPTIS®, to streamline MDR & IVDR document creation & maintenance.
62%
CAPTIS utilization resulted in a 62% reduction of time in data gathering tasks.
30%
Overall reduction of nearly 30% of time in systematic literature review
45%
45% time savings in searching and archiving full-text articles using CAPTIS
100%
Users saved 100% of time because duplicates are detected automatically.
13:16 HOURS
Overall savings of 13 hours and 16 minutes from each literature review.
Experience the power of CAPTIS®, with its groundbreaking Document Creation & Maintenance Module.
Celegence team has extensive experience writing EU MDR & IVDR compliant documentation. Based on this experience, we have built a groundbreaking proprietary technology solution, CAPTIS®, to streamline MDR & IVDR document creation & maintenance.
Data Dictionary
Automated Abbreviations & Citations
Content Linking & Traceability
Create a CAPTIS®Link:
Stay Aligned with Collaboration & Review
Inserting Automated Literature Report
15 Apr, 2025
26 Feb, 2025
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.
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