Challenges of MDR

  • MDR Poses a significant challenge for your organization.
  • Clinical Evaluation Standards are Increased (more detail in CERs)
  • Literature Searches must be comprehensive
    (global search, intricate review process)
  • Post Market Surveillance Requirements are
    significantly more thorough
  • Timelines are slashed, reporting intervals are
    shortened
  • This means more work for your (already stressed out) team. For most manufacturers, it simply isn’t feasible to either staff a full time writing team, or continuously hire contractors to get their Literature Searches and CERs completed on time.
  • The workload is too high for teams already responsible for every other piece of regulatory affairs responsibility.
  • In addition to all of the above, after initial filings are completed:
  • Post Market Clinical Followup must be completed at the appropriate intervals

  • Device Vigilance plans established in your CER
    must be adhered to consistently.

  • All PMS plans must be carried by your team in
    addition to creating new CERs and Literature
    Searches for new devices.

Guaranteed To Meet MDR Requirements

Leave no doubt that your CER and Literature Searches will
hold up to even the toughest Notified Body scrutiny.

Adopt our process completely and receive a ‘done for you’ solution,

OR

Let us make your CER writers’ job easy by adding our bulletproof (and modular) Literature Searches to your workflow.

Whether you are preparing for your first MDR certification submission, or wish to renew an existing MEDDEV device (while preparing for future MDR requirements) our process is designed to meet and exceed.

  • Our proprietary software system makes our team incredibly efficient (high capacity, high quality)
  • Our writers are qualified (according to Notified Body Standards) and specialize in Literature Search and CER writing.
  • Our proprietary software system makes our team incredibly efficient (high capacity, high quality)
  • Our writers are qualified (according to Notified Body Standards) and specialize in Literature Search and CER writing.

Our Qualifications and Experience

EDWARD DROWER M.S.
(Full CV Available Upon Request)

Who will be conducting your research and writing?

  • Over 30 Years of Clinical Experience (In Drug and Medical Device

  • 15+ CER and Literature Searches Personally Authored for EU
  • Meets and exceeds all criteria for an MDR Clinical Evaluator.

Some of Our Medical Device Experience

Blood pressure cuff, Pediatric Face Masks, Surgical gloves, Exam gloves

Needles, Wound drains, Surgical blades, Urinary Catheter,
Umbilical Cord Clamp, Disposable IV Sets, Drain Bags
(active),Wound closure, Surgical glue, Super absorbent
dressings, Needless, Injectors
IV pumps, EEG Devices
Spinal Implants

Notified Bodies We Have Worked With

Guaranteed To Meet MDR Requirements

Leave no doubt that your CER and Literature Searches will
hold up to even the toughest Notified Body scrutiny.

Summary

The Literature Search is the driving component of the CER and must be completed to the absolute highest current standards (MEDDEV 2.7.1) and future MDR expectations. An easily readable and Compliant Template must be used in conjunction with error-free analysis and classification of all relevant Literature.
In addition, a concise Search Protocol must be formally established prior to any Literature Review.

CiteMed Literature Searches Include

Comprehensive Search (Multiple International Literature Databases)
  • PubMed
  • PubMed Central
  • Cochrane Library
  • ClinicalTrials.gov

  • Google Scholar (Optional: $495)
Adverse Event Database Search
  • FDA Maude
  • UK (MHRA)
  • Italy, Ireland, France Available Upon Request (Optional: $295 Each)
Up to 20 Search Terms (more available if necessary)
A Detailed and robust Search Protocol designed for maximization of results but flexible for life-cycle risk management
Trending Data (only for clients utilizing repetitive CiteMed Literature Reviews)
  • archives (all previous searches performed by CiteMed are stored and used as reference material in future reports/searches)

User-friendly templates are designed for the efficiency reviews by the NB Assessors
Comprehensive Assessment of Equivalent Devices
Quantitative analyses of search results
  • Summary tables that can be imported easily into QMS/PMS systems/software

Benefit-Risk Assessment conclusions

MEDDEV 2.7.1 Rev 4 and MDR Compliance

Build a Superior Clinical Foundation

The Literature Search is the most commonly cited document in your CER submission when a Notified Body has questions or concerns. In order to ensure smooth submissions (and avoid wasted time in correspondence and corrective actions) it’s essential that your Literature Search is comprehensive and well designed.
Your Literature Search must cover ‘enough’ search terms, process all relevant studies/clinical data, and summarize your results (with poignant commentary on all relevant articles). This document is often hundreds of pages and can be incredibly challenging to format without the proper tools and process.

Literature Search Fee Structure

Quantity, Device Classification, Price (USD), Timeline (Standard)
Number of Product Searches Classification Price-Range Standard Timeline *
1 (One off Search) Class I, IIa, IIb See SOW 4-6 Weeks
2-5 Annually Class I, IIa, IIb See SOW 3-4 Weeks
6+ Annually Class I, IIa, IIb See SOW 3 Weeks
Additional Search Terms/DB NA See SOW NA
* Expedited requests less than those listed will be subject to a 50% surcharge.

Save Your Staff and Cut Costs

Our Timeline Will Shock You

Literature Search

How can we be so efficient?

The reason we are able to complete MDR compliant Literature Searches in such remarkable time frames while actually improving quality is due to our proprietary Literature Review System.
This software solution is used by our writers to handle all organization/display of the research including generating the final output. This ensures that the deliverable is mistake-free and allows our writers to focus on what’s most important; reviewing literature and writing assessments for your products. Your CER writing team won’t be able to keep up!

Supercharge Your Regulatory Affairs
Writing Team (Or Borrow Ours)

We Are NOT an Outsourced Network of Consultants and Regulatory Writers

We deliver finished products, not endless hourly contracts. We deliver your clinical evaluation on a firm timeline at a fixed cost. There are no middle man costs to absorb.

We Are NOT a Corner-Cutting Piece of Optimization Software

A talented, committed medical writing staff is essential. We maximize their focus on product knowledge and medical judgment and minimize time wasted on low-value work.
  • A Fresh Approach
We’ve brought together a core team of experienced technologists and regulatory affairs experts to rethink the way research and clinical evaluation is done.
  • Laser Focused Writing Staff
We let our staff focus exclusively where they add value: on research and writing. Our proprietary software takes the complexity of report organization, corrections and final document formatting, checks, and standardization.

Clinical Evaluation Report

Summary

Your EU MDR Clinical Evaluation Report will incorporate your Literature Search, define Post Market Surveillance (and Clinical Followup) Plans, and deliver your comprehensive conclusions of benefit-risk.

A Comprehensive CER Template

  • Our template addresses ALL newly defined EU MDR requirements of Clinical Evaluation
  • Our team will thoroughly assess all of your available Clinical data/reports and seamlessly integrate into the final
    document.
  • Post Market Surviellance and Safety Update Reporting protocols will be created (if necessary) and discussed in detail.

  • Benefit-Risk Determination based on all Product Safety Data and the results of the Literature Search.

Clinical Evaluation Report Fee Structure

Quantity Classification Price-Range Timeline
1 Class I, IIa, IIb See SOW 6-8 Weeks
2-5 Annually Class I, IIa, IIb See SOW 5-7 Weeks
6+ Annually Any Inquire for Pricing
Note: Pricing on Follow-Up Updates and Renewals (after CiteMed has conducted an initial CER/Update) are done at lower costs and shorter timelines.

Is your Post Market Plan MDR Ready?

New Requirements Mean Extra Work For Your Team

Adopting the MDR standards for your Post Market Surveillance will mean increased efforts and responsibilities when it comes to your devices.
  • Post Market Clinical Follow-Up (PMCF) on 1-2 Year Intervals
  • Shortened Response Time for Vigilance and Adverse Events
  • Significantly Increased Detail Across Reporting and Trending Data
Committing to the increased standards in your written PMS plans is one thing. Actually following through and executing a PMS plan year after year is another entirely.
The CiteMed team has built several solutions that guarantee consistency and accuracy in your Post Market Surveillance Plans. Our system and team will ensure that your plans are being carried out across ALL of your product offerings.

Simplified Periodic Update Solution

Summary

Through our proprietary system, we have the ability to offer continuous safety monitoring and periodic update reports that offer enhanced PMS capabilities and risk management based on individually established Device Search Protocols.
CiteMed can routinely scan Adverse Event Databases such as FDA MAUDE, alert you of critical incidents and provide comprehensive routine and annual reports to bolster your PMS strategy.
Our system will allow Sponsors to provide NB’s with unprecedented levels of updates while improving the Sponsor’s confidence to effectively manage PMS commitments and grow confidence in your companies ability to effectively manage your products’ PMS commitments.

Key Features

  • Custom built alerts and reports to fit any product profile of PMS needs.
  • Consistent, reproducible, confirmation of data/searches in adverse event dataabases.
  • Improved Medical Monitoring Efficiency while reducing
    review time and costs
  • Demonstrate Unprecedented Corporate-Level Commitment towards MDR compliance through Proactive Safety Monitoring

  • Generate meaningful trending data throughout historically managed searches leading to higher safety assurance, potential trigger events, enhanced Literature Review/CER Updates
  • Product profiles on file with CiteMed for simplified renewals. Leverage Existing Search Terms/Protocols from Previous Literature Review while easily adjusting terms as needed.
  • Turn-key reports and timely renewal reminders maximize your staff focus and scheduling.

  • MDR Certification ready

An Automated Post Market Surveillance Solution

Establishing your commitment to proactive safety/incident monitoring has become an essential part of a Post Market Surveillance strategy for any future review.
CiteMed’s Systems optimize the Literature Search process to not only support your CER and PMS strategy but establish a recurring safety monitoring network. This solution can be leveraged for immediate critical alerts and for recurring update reports on all products leading to reduced PMS time and costs.

Deliverables

  • A periodic report (e.g. quarterly, annual) that contains the results/counts of predetermined search criteria for each product.
  • Product Alerts Emails. Alerts can be customized to match your established severity threshold requirements with routing to appropriate personnel. All other alert levels are stored in a customized product database for incorporation into an annual ‘update’ report and additional future Literature Search/CERs.
incidents/recalls (e.g. MAUDE) can be searched daily in incident databases such as FDA Maude, MHRA Events Recalls, HPRA Safety Alerts, Ministero della Salute Safety Alerts

Periodic Update Solution (PMS) Fee Structure

Quantity Classification Price-Range Report Timeline
1 Annually Class I, IIa, IIb NA 1 Week
2-5 Annually Class I, IIa, IIb NA 1 Week
6+ Annually Any Inquire 1 Week

Notified Body Correspondence

Summary

When communicating with your NB, it is crucial that your messaging not only be clear but that you systematically address all concerns.
At CiteMed we guarantee our work and will offer our insights and the guidance when it comes to corresponding effectively with NB directly or working in conjunction with your Regulatory Group at no additional cost.
Citemed will offer assistance in managing NB responses that reference the your filings unrelated to previous CiteMed work at a rate of $250/hour.