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.
Why us?
Meeting
Deadlines
Guaranteed Approval
VIP
Service
Peace
of Mind
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
Medical Device Notified Body Feedback – EU MDR: A Case Study
Getting notified feedback on your medical device clinical evaluation can be overwhelming. Even if the changes required are minimal, the feedback sheet typically doesn't look minimal. They do like [...]
Switzerland’s Medical Device Regulation and the EU Regulations
The medical device industry is thriving globally. Not only in European Union countries, but the influence is also seen in neighboring countries as well. Switzerland, in particular, has become [...]
EU MDR: Combination Products – An Overview
We all know and love (ahem) the EU MDR (2017/745). And although it is defined as the EU Medical Device Regulation, it applies to certain other devices as well. [...]
Free EU MDR Templates – Download Here
Before you begin (or continue your EU MDR Journey), make sure you're operating off of comprehensive templates. This article will cover a brief overview of our own templates (some free, [...]