Literature Search
MEDDEV 2.7.1 rev 4 and EU MDR Compliant
Global Lit Search (5+ Databases)
Notified Body Accepted Writers
Fixed Price. Firm Timeline (~2 Weeks)
Data Validation and Peer Reviewed
Clinical Evaluation Reports (CER)
MEDDEV 2.7.1 rev 4 and EU MDR Compliant
Use our Approved Template or Your Own
Literature Search Included (if needed)
Fixed Price. Firm Timelines
Dedicated CER Writer
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Our Clients Say
“ 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.”
Quality Director, Medline Industries
Get Your Submission
Right The First Time
No one knows your products and their use history better than you and your team. There isn’t a consultant or medical writer on this planet that can come in and produce the level of depth that you can. This is why we so often tell clients (that have the staff) to write their own CERs.
In our experience, the CER is not the problem. It’s the Literature Search that (when lacking strong clinical evidence) derails timelines and ultimately is scrutinized by your Notified Body.
Why? Because very few people have the time and experience to conduct bulletproof EU MDR Literature Searches on their own.
It’s simply too much unnecessary work to burden your team with. Save your CER Writer time with our approach.
Where Are You In the Journey to EU MDR Compliance?
Use Our
Notified Body
Approved Process
Global Literature Search
Our Literature Search documents are comprehensive enough to be used for submissions in multiple countries.
Why Is Literature Search
So Crucial for a CER Writer?
Literature Search is the foundation of your device CERs. If your’e in charge of compliance on multiple products, then you also know that EU MDR poses a serious challenge to your team and your existing timelines. If you are a smaller manufacturer, you likely have only one or two folks tasked with all things regulatory and quality.
Larger companies have larger teams, but also exponentially more products to support. They also are facing tightening budgets and shortened timelines. In fact many of the larger firms we speak with are already struggling to keep up with their Assessor’s comments.
MDR has forced too great of a burden on manufacturers to comply with year after year. As a writing or regulatory manager you have several options in order to get all of your submissions completed on-time (and correctly)
And it’s not just a question of deadlines either. Anyone can slap together reports that get rejected. We’re in the business of submitting reports that don’t come back with a list of corrections and scrutiny from the notified body.
And it’s not just a question of deadlines either. Anyone can slap together reports that get rejected. We’re in the business of submitting reports that don’t come back with a list of corrections and scrutiny from the notified body.
The CiteMed approach is designed to obliterate the extra workloads for your team and enable them to focus on review and the overall submission.
No Inflated
Consultant Budgets
and Dragging Timelines
The workloads created due to MDR are like an avalanche tumbling onto already overworked and underappreciated Regulatory and Quality teams. Throwing more manual labor (consultants) is often cost prohibitive and slow.
CiteMed prefers to use a hyper focused team of medical writers and equip them with world-class software solutions to ensure accuracy, validated data, and a high quality readable deliverable. All at Fixed Costs and on Firm Timelines.
How is
Our Approach Different?
What happens when you take a team of Regulatory Affairs Veterans and combine them with Silicon Valley Engineers? The result is a proven research process and a peer reviewed output.
Our team has the skills and tools to make a 500 page dense research document mistake free and readable by Notified Body assessors with the regulatory submission experience to back it up.
A Complete Solution to Satisfy Your Notified Body Assessor
Never Sacrifice Quality
Need Consistency?
Use Our Process
EU MDR
What are your Costs?
The additional costs of compliance due to MDR can derail your timelines and devour your budgets if they’re not understood fully.
We get calls every week that start off first thing with “How much does your Literature Search cost? We have a quote for X amount, can you beat it?”
While we completely understand that everyone has a budget, and recent times are rough… We need to make one thing very clear.
Not all Literature Searches + CERs are created equal. And the costs of NOT writing them properly and thoroughly can be extensive.
You Can’t Afford Low Quality Submissions
An Expert
By Your Side. Always.
We are so confident in the quality of our submissions that we guarantee you complimentary help on any notified body inquiries related to them.
The only reason we can ‘afford’ to do this is because we rarely get any questions or requests for clarification for Notified Body Assessors.
However, nobody is perfect and the team at CiteMed is no exception. Sometimes questions pop up, or oversights are made.
This is exactly why we promise to stand by our submissions and work with your NBs to sort out any discrepancies.
What You Receive
Working With Us
