Your On-Demand
Clinical Evaluation Team
Full Clinical Evaluation Report (CER) services and the Industry’s Fastest Literature Review for EU MDR.
Ace your audits, maximize your team’s time and budget.
Problems We Solve
How we work
Are You a Fit?
-Who We Serve
Medical Device Manafacturers
Small/medium
Enterprise
The CiteMed Edge
The CiteMed Edge
What makes our approach unique is our blend of world class regulatory talent, leading regulatory software tools, and (almost) obsessive customer service. Here are some of the highlights:
Your Literature-Driven
Regulatory Process
Consistent and effective Literature Search/Review strengthens your entire
regulatory workflow.
Cite Medical Literature Search
Dashboard
Our team works with our proprietary platform
to search, process, and store all scientific
literature related to your devices.
Clinical Literature
We search globally and utilize an extensive list of
databases such as PubMed Europa, Embase, Cochrane, Clinicaltrials.gov, and more.
Vigilance and Adverse Events/Recall
We search and record data from every
country that maintains a public database for
Adverse Events and Recalls.
Cite Medical Literature Review
The Literature Review document you receive
is comprehensive and designed for easy
integration into your CER, PMCF, or PSUR.
Clinical Evaluation Report
Whether it’s a first time submission or an
update, bolster your CER with a bullet-proof
Systematic Literature Review.
PMCF Report
While rarely the only requirement, an update
demonstrating strong support from Clinical
Literature is a great addition to your PMCF
commitments.
Periodic Safety Update Report
Our Literature Reviews bolster your PSUR narrative and
showcase your team’s diligence in updating your safety
information and benefit-risk statement.
Our Trending Publications
How to Prepare for a Clinical Audit
Audits are not fun. That's general knowledge. Ask anyone, and they will tell you. But they will also tell you that being audited is a normal part of being in [...]
Unpacking State-of-the-art: Why Does It Matter to My Medical Device Clinical Evaluation?
The European Medical Device Regulation (EU MDR, 2017/745) has been called many things since it was first drafted, some of which cannot be repeated here. One thing it has [...]
Fundamentals of Clinical Evaluation Reports: A Beginner’s Guide
The clinical evaluation reports are the final transcript for medical devices. Allow us to explain. So, you know how in high school, you had to earn good grades and maintain [...]
An Overview of the CE Marking Process in the European Union
You want to sell your device in the European Union and start the CE marking process. But after reviewing the MDR and the guidance documentation, you begin to doubt the [...]