“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
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”
Comprehensive Literature Search In Under 3 Weeks
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
Our Searches Are Used Globally
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
Our Process
The Price of Delays
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