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Big enough to get it done, small enough 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
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.
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.
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. Cite Medical produced elegant reports that were easy to read despite their length and incredible detail
Our Trending Publications
Essentials for Your EU MDR Checklist
The Medical Device Regulation (MDR) has been a regulatory framework since 2017. The MDR is designed to ensure that medical devices are safe, effective, and high-quality. While the EU had given time for the manufacturers to adjust to the [...]
Post-Market Surveillance – Responsibilities of National Regulatory Authorities
We've explored post-market surveillance (PMS) for medical device manufacturers many times, for example, in our articles on post-market surveillance under the MDR, MDR post-market surveillance compared to the IVDR, and the relationships between literature search and clinical evaluation [...]
Classifying In Vitro Diagnostic Medical Devices Under The MDR
May 26, 2022, marks the start of the 5-year staggered implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR, 2017/746). Unlike the In Vitro Diagnostic Directive (98/79/EC), the IVDR emphasizes continuous lifecycle management of in vitro diagnostic medical [...]
A system honed to next-level perfection.
1 You get in touch.
2 We get to work.
3 You receive the documents.
