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

Clinical

Evalution

Get support from seasoned CER writers.

Systematic

Literature

Review

Done for you by experts,  or use our industry leading software.

Post Market

Surveillance

and Vigilance

Handle your PMS and Vigilance needs year after year with ease.

Emergency

Damage

Control

Need to organize audit responses fast?  We’ve got you.

Regulatory

Templates

Small team and tight budget?  Use our constantly updated template packages.

Training

Courses

Learn from QA/RA practitioners who have been there before.

Regulatory

News Updates

Newslatter

Stay on-top of the latest industry news. Free.

How we work

Done For You

Don’t have the time, or a particular type of submission experience?

Our regulatory team is stacked with experience, and if you look closely the occasional battle scar.

Done With You

Looking for on-demand help when you need it? (and only when you need it)

Sometimes an expert review of a doc or SOP is all it takes to polish a submission. Other times you might need more.

Regardless of your level of assistance required, our team is here to help when you need it and get out of the way when you don’t.

Do It Yourself

Under budget, or a freelance writer looking to get to next level? Our training programs and templates will get you there.

Are You a Fit?
-Who We Serve
Medical Device Manafacturers

Small/medium

Enterprise

Consultants

and CROs

Freelance

Medical Writers

Our Previous Clients

Our track record speaks for itself, but we won’t say no to a little extra flattery from clients!

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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:

  • High quality Systematic Literature Review on Industry Leading Timelines

  • CER Team Boasting 100% Acceptance Rate in Europe

  • Systematic Literature Review Software saving teams over 20+ hours per Literature Review

  • Dedicated Account Reps to manage your project, and be your single point of contact.

  • Shortest time to Proposal, and Project Kick Off. Zero time wasted, all to improve your delivery timeline.

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