EU MDR Vigilance/PMS Monitoring on AutoPilot

Consistent and comprehensive reporting of Adverse Events and Recall data for your entire device portfolio.  See our complete process, pricing, and output below.  We Guarantee EU MDR Compliance

Your End to End Vigilance Reporting Solution for EU MDR

If You Are:

Looking for consistent searching, reviewing and reporting that will easily integrate and be compliant for EU MDR PMS Plans and PSURs

Short on staff and resources to conduct multiple Vigilance reports every quarter.

Perfectionists that want a consistent system and operating procedure to satisfy Post Market Surveillance requirements.

In need of a single centralized platform to securly store your AE Reports and trending data over time.

SEE OUR APPROACH

Consistent Vigilance Reporting (On Any Interval)

It’s a full time job searching and compiling Adverse Event Data for all of your medical devices each month, quarter,
and year. With the Cite Medical Vigilance Module, all of your data (reviewed by the team) is accessible in one single
location.

Medical Device Vigilance
Global Data Sources

Our team and system can collect your Adverse Event
data from any desired databases.

Vigilance Reports on Any Interval

Our team can search and review on timeframes as short as Weekly, or as long as Yearly.

Online Dashboard

View all data, finalized vigilance reports,
and trending analysis online.

Take Us For a Test Ride

See our process, pricing, and Vigilance Report output examples

SEE OUR APPROACH

How It Works

1. Searching and Data Ingress

CiteMed (Through Automation and Careful Human Auditing) Collects Adverse Event Data from all of your chosen global sources

2. Expert Review of All Search Results

Our team of medical writers reviews the results and classifies any relevant Events for you to be included in the next Vigilance Report. (this is optional).

3. All Results Made Visible on Your Dashboard

Search results as well as our team’s reviews/classifications are immediately available for you to access on your CiteMed Dashboard.

4. Vigilance Report Document Is Delivered

On your chosen time interval, CIteMed delivers an Adverse Event Report to you via email and accessible directly on your CiteMed Dashboard.

What’s Included in Your Vigilance Reports?

Trending Data

Trending Data (based on search results, and your previous reports)

Result Counts

Summary Table and Count of All Results by Data Source

Expert Filtered Search Results

List of Relevant Adverse Events/Recalls Retrieved

Full Search Archive

Full Appendix of All Search Results. Archived

Your Vigilance Reporting Plan Starts Today

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