Medical device certification,
reimagined

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.

High-quality

Error-free

Timeline-ready

Best part? It’ll be APPROVED

47833

Articles Reviewed

100%

Success Rate

298

Products Monitored

5432

Alerts Sent

Your Literature-Driven
Regulatory Process

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

CiteMed 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.

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
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.

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
recertification.

Newer-fail(seriously!), gorgeously formatted, and an absolute joy to
integrate
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

  • Software as a Medical Device

CER for Software as a Medical Device in the EU

January 24th, 2023|Comments Off on CER for Software as a Medical Device in the EU

The medical device industry has been changing bit by bit every day, and one of the significant changes is the addition of technology to medical devices. While medical testing devices, scans, and robotic surgical instruments were already in use, [...]

  • Vigilance Reporting Under the MDR

Vigilance Reporting Under the MDR: Insider’s Guide

January 17th, 2023|Comments Off on Vigilance Reporting Under the MDR: Insider’s Guide

Implementing the European Medical Devices Regulation (MDR; 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR; 2017/746) have significantly increased post-market surveillance and vigilance system requirements for medical device manufacturers compared to previous regulations.   The regulations are [...]

  • UK MDR

The UK MDR and The EU MDR: What Are The Differences?

January 10th, 2023|Comments Off on The UK MDR and The EU MDR: What Are The Differences?

UK MDR is the primary standard that mandates requirements for anyone selling medical products in the UK, as it is a vast market that often goes unexplored. After the UK left European Union, there has been some confusion [...]

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
contact.

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
requests.

We send the final documents for your CER
submission.

4  You enjoy hassle-free
automation.

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

You get reminders to update your
documentation as needed.

You enjoy painless, efficient recertification
and vigilance processes.

Ace your audit without breaking a sweat.