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
The Top 5 Regulatory Requirements for the Medical Device Industry
Being in the regulatory industry is not as cut and dry as most people think. Sure, you do have to read a lot, usually till your eyes bleed, but [...]
Why Your EU MDR Literature Review is Your Clinical Evaluation Bottleneck
Clinical evaluations for medical devices are long and arduous tasks. But what many medical device manufacturers fail to take into consideration is that clinical evaluations are living processes. [...]
Understanding Global Regulatory Authorities in the Medical Device Industry
You know what is common in all countries? No matter the geographical position, the culture, the people or religion? No one wants medical devices that are unsafe. Seriously, there [...]
Performance Plan Evaluation Under the EU IVDR 2017/746
Most of us are familiar with clinical evaluations for medical devices. Easy peasy. But when it comes to the equivalent for in vitro diagnostic medical devices, the performance evaluation, [...]