Your Expert-Driven Process to

EU MDR Approval
– CER Writers and
Literature Search

Literature Search

check icon MEDDEV 2.7.1 rev 4 and EU MDR Compliant

check icon Global Lit Search (5+ Databases)

check icon Notified Body Accepted Writers

check icon Fixed Price. Firm Timeline (~2 Weeks)

check icon Data Validation and Peer Reviewed

Clinical Evaluation Reports (CER)

check icon MEDDEV 2.7.1 rev 4 and EU MDR Compliant

check icon Use our Approved Template or Your Own

check icon Literature Search Included (if needed)

check icon Fixed Price. Firm Timelines

check icon 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

Your Expert-Driven Process to

Literature Search or CER?

Sometimes the answer is YES, other times a medical writer will make life much easier. Schedule a free consult with our team to find out what’s best for your specific situation

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?

I Want to Write My Own

I am a CER writer and am looking for more detailed
information on what’s required of EU MDR Clinical
Evaluation Reports (CERs) and Literature Searches as
well as how to write them.

I Want a Full Solution

I’m familiar with what’s required and am looking
for high quality Clinical Evaluation Reports (CERs)
or Literature Searches to be completed before my
deadlines and authored by experienced and NB
approved medical writers.

Use Our
Notified Body
Approved Process

  • 100% Acceptance Rate In Europe
    (and several other countries)
  • Dedicated US Researchers and Medical Writers,
    and dedicated CER Writers. They have the experience
    and skill to address the most pertinent clinical
    literature to your devices.
  • Use Our Proprietary Template. Our thorough Lit.
    Search and clinical evaluation report templates
    present a powerful image of competency.

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

Detailed
Search Protocol

Our process begins with a concise and comprehensive search protocol that ensures consistency with our search and makes review easier for your Notified Body Assessor

Comprehensive
Database Search

PubMed
PubMed Central
Conchrane Library
ClinicalTrials.gov

Validated
Search Results

Computer Verified Summary Tables are Generated to validate all search results, remove duplicates and yield a 100% accurate result.

Expert
Writing

Our Experienced CER Writing team reviews all relevant research and writes detailed benefit-risk analysis on all retained articles.

Never Sacrifice Quality

Guaranteed Search Result
Validation

All searches have their results
validated once by our staff, and again
by our research validation system.

Duplicate entries are removed, and
perfect search summaries are
generated with 100% accuracy for
inclusion in your final report.

Written and Peer
Reviewed by our Regulator
Heavyweights

All searches have their results
validated once by our staff, and again
by our research validation system.

Duplicate entries are removed, and
perfect search summaries are
generated with 100% accuracy for
inclusion in your final report.

Don’t Risk
Delays

A poorly conducted review or
convoluted deliverable will always
bring further Notified Body scrutiny.

This can delay approval by months
and add substantial headache to go
along with lost sales revenue.

Custom Solution. Fixed Pricing. Firm Timelines.

Need Consistency?

Use Our Process

Speak with you dedicated rep about your products, their classifications and the requirements for your EU MDR Literature Search

Define the Target – Identify your goals and the products you intend to market

Assess Viability – Determine preliminary time/cost estimates and potential risks

Onboarding – Complete initial on-boarding agreements

Choose Database Sources – Determine which Databases/Journals will be queried for research.

Discover Terms – Work with us to find the optimal search terms for your product

Generate Protocol – Build and Finalize your Search Protocol

Research Collection – All articles are collected and stored in the Research Management System

Categorization – Relevant articles will be flagged for in-depth review, while irrelevant articles are categorized as non-essential

In Depth Analysis – Top research articles are analyzed deeply and written about at length

Polished Product – You will see a final, fully formatted product customized with your branding

Revisions – Our staff is prepared to complete revision requests in the same business-day

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

Regulatory
Staff’s Time

Due to the labor intensiveness,
the formatting, days/weeks
spent validating data and error
checking manually it’s simply
not worth your time.

Loss of market
share to competition

Don’t lose precious ground to
competitors already operating
the EU markets.

Time to
market

Lost Revenue
Even the smallest oversights can
lead to endless correspondence
with your Notified Body (who is
flooded with work and will be
even slower to respond)

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

  • Dedicated Point of Contact
  • Direct Access To Our RA Experts
  • Guidance On Notified Body Inquiries
  • All Your EU MDR Questions Answered

Start Your Complete Literature Search Solution Today