Your Expert-Driven Process to EU MDR Clinical Evaluation Approval

Literature Search

  • MEDDEV and EU MDR Compliant 

  • Global Lit Search (5+ Databases)

  • Notified Body Accepted Writers

  • Fixed Price. Firm Timeline (~2 Weeks)

  • Data Validation and Peer Reviewed

CER

  • MEDDEV and EU MDR Compliant

  • Use our  Approved Template or Your Own

  • Literature Search Included (if needed)

  • Fixed Price. Firm Timelines

  • Custom Post Market Surveillance Plan

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

Should you be writing your own Literature Search or CER?

Sometimes the answer is YES! Schedule a free consult with our team to find out what’s best for your specific situation
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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 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 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.

Where Are You In the Journey to EU MDR Compliance?

I Want to Write My Own

I’m looking for more detailed information on what’s required of EU MDR CERs and Literature Searches as well as how to write them.
Free Resources

I Want a Full Solution

I’m familiar with what’s required and am looking for high quality CERs or Literature Searches to be completed before my deadlines.
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Use our Notified Body Approved Process

  • 100% Acceptance Rate In Europe (and several other countries)
  • Dedicated US Researchers and 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 CER templates present a powerful image of competency.

Why Is Literature Search So Crucial?

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.

 

What you really need are submissions so thoroughly written and beautifully organized that they glide through the NB’s review process.

 

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 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
Cochrane Library

Validated Data

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

Expert Writing

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

Never Sacrifice Quality

Custom Solution. Fixed Pricing. Firm Timelines.

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Need Consistency? Use Our Process

Initial Scope

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

Discovery – Protocol Definition

  • 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 and Writing

  • 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

Report Generation and Review

  • 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

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

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