Medical device certification,

Full Clinical Evaluation Report (CER) services for EU MDR.
Never fail an audit again.

Big enough to get it done, small enouth to care.

Medical device certification is a labor-intensive, time-consuming process.

You’re likely frustrated by how many hours your medical writers spend on
formatting alone for the Clinical Evaluation report (CER) documentation.

Hand of the whole headache to a team with the manpower to get it done,
and the attention to detail you deserve.

When you work with us, you can set your expectations high.




Best part? It’ll be APPROVED


Articles Reviewed


Success Rate


Products Monitored


Alerts Sent

Your Literature-Driven
Regulatory Process

Consistent and effective Literature Search/Review strengthens your entire
regulatory workflow.

CiteMed Literature Search

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,, 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.

CiteMed 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

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.

The Ultimate Literature Search & Review.
Give your CER package a powerful upgrade.

Our Literature Search and Review enhances your entire CER package and
gives your team their time back – so you can focus on the rest of the

Newer-fail(seriously!), gorgeously formatted, and an absolute joy to
with all the rest of your CER and PSUR documentation, your LITR
docs are poised to go from pressure to pleasure.

Ready for never-fail CER and PMS documentation?

Don’t Take Our
Word For it.

I’ve never seen such a streamlined process for literature search and review. CiteMed produced elegant reports that were easy to read despite their length and incredible detail

Our Trending Publications

  • Why Your EU MDR Literature Review is Your Clinical Evaluation Bottleneck

Why Your EU MDR Literature Review is Your Clinical Evaluation Bottleneck

September 12th, 2023|Comments Off on 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.   They ebb and flow. And just like bodies of [...]

A system honed to next-level perfection.

1  You get in touch.

You describe your needs and we make sure
we’re a good fit.

We assign a dedicatedproject manager to
your case; they’ll serve as your point of

You rest easy, knowing your CER will be
professional and timely.

2  We get to work.

Our in-house team of writers does the
review and writing.

Our proprietary software takes care of
formatting and error-correcting.

We’re in touch throughout with updates
and to request necessary documents.

3  You receive the documents.

You get them much faster than with any
other service.

You give us your feedback and revision

We send the final documents for your CER

4  You enjoy hassle-free

All scientific literature, search results,
documents, and results get archived in our

You get reminders to update your
documentation as needed.

You enjoy painless, efficient recertification
and vigilance processes.

Ace your audit without breaking a sweat.