Never Miss Another CER Deadline

Without Hiring More Staff or Risking Non-Conformity

“There’s just not enough time to satisfy your Notified Body Reviewer…”

If you are a manager or executive responsible for getting your medical devices approved by your Notified Body, then you likely are facing some of these issues regarding your Clinical Evaluation Reports:

  • Excellent Medical Writers are incredibly difficult to hire, train and onboard.

  • Costs of hiring contractors for all writing work are astronomical.

  • Even with an increased staff, deadlines are still being missed.

  • Once CERs are completed and staff is downsized, new staff will need to be hired every few years to update documentation.

EU MDR has created a problem. Companies with multiple products must update their CERs to a new and far stricter standard. It simply takes too much time to update each template, and medical writing staff’s are drowning in work.

Many companies are attempting to hire an army of Medical Writers to fill the gaps in productivity and hit those crucial submission deadlines. Unfortunately everyone who attempts this experiences a few major challenges.

Before you hire another general CER Writer

The CiteMed process brings together silicon valley technologists and seasoned Regulatory Affairs Professionals to deliver the Clinical Literature Search and Review section of your CER. By using our process your team can benefit from:

  • Precious Time Saved – Let your writers focus on the heart of your CER (no wasting time sorting thousands of articles, formatting outputs, and wrestling with giant summary tables in Word/Excel)

  • Lightening Fast Turnaround (we handle the time consuming literature search and make your writer’s job significantly easier)

  • Seamless integration into your existing SOPs and Templates (we craft our Literature Searches to fit within your CER templates from the start)
  • Fixed Pricing that will keep your budgets intact
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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

Comprehensive Literature Search In Under 3 Weeks

Literature Search

The CiteMed Literature Review

  • MEDDEV 2.7.1 rev 4 and EU MDR Compliant

  • Global Literature Search (5+ Databases)

  • PICO (performance/safety) and State of the Art Review

  • Fixed Price. Firm Timeline (~3 Weeks)

  • Data Validation and Peer Reviewed

  • Seamless Integration With Your SOPs and Internal CER Templates

  • Reviewed for Performance & Safety AND State of the Art

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What’s In Our Literature Review?

Your legacy MEDDEV Literature Reviews will no longer be accepted by Notified Bodies.  Check out our Process/Template to see how we leave zero room for Auditor scrutiny.

Our Searches Are Used Globally

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How Our Process Supports Your Team

  • 100% Acceptance Rate In Europe (and several other countries)
  • Zero On-boarding Costs (We start immediately)
  • Seamless Integration Into Your CER Workflows

  • The Most Thorough Literature Review in the Industry

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A Complete Solution to Satisfy Your Notified Body Assessor

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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

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Comprehensive Database Search
  • PubMed
  • PubMed Central
  • Cochrane Library
  • ClinicalTrials.gov
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Validated Search Results

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

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Expert Writing
Our Experienced Writing team reviews all relevant research and writes detailed PICO and State of the Art analysis on all retained articles.

Custom Solution. Fixed Pricing. Firm Timelines.

Our Process

Literature Search

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

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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

The Price of Delays

Regulatory Staff’s Time

Let your CER writer’s focus on the draft while we deliver the clinical literature search.

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)

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