A Targeted Approach to EU MDR
You already know that the Literature Search and Review is the cornerstone of your Clinical Evaluation Report.
If your team has been working on these for awhile, then you also know it can be the most labor intensive and time consuming part of the entire process. The formatting alone can waste substantial hours of your writer’s time. Hours much better spent on the more product knowledge intensive parts of your submission.
The CiteMed team was formed to be able to deliver a high volume of beautifully written and formatted Literature Reviews on timelines that will enable you to meet your EU MDR goals.
We don’t outsource, all research is read and reviewed by internal qualified writers dedicated to your product lines.
We leverage a software platform that we built in-house to perfect the formatting of uniform and error free submissions. Humans read and write, while we let the machines handle the arduous tasks of formatting and error handling. The result is consistency across all of your literature review submissions.
Know Where to Start – Our approach can drive your whole regulatory review process.
Speed – Collaborative, rapid decision point schedules keep your project moving. You will have trouble keeping up
Accuracy – Internal systems validate research data
Fixed Pricing – Upfront costs established based on a proven and logistic model.
Human and Technology Driven – State of the Art Reports, Follow-Up Reporting Requirements and Research Management Software visually manages all projects and stages of completion.
We are committed to keeping our approach current with Industry standards and improving our tools to meet the strictest reviews of Notified Bodies.
Streamlined Process
We’ve taken a once cumbersome process of approval/revision and flattened it out to slash delivery time and avoid endless revisions for the new EU MDR standards.
Top Research
We search major safety databases and Published Journal databases for specific key words related to your product or concept product.
Proven Reg Staff
We have in-house MD writers that review all research for your submissions.
Post Market Surveillance
All projects are stored in our product Vault for ease of future compliance filings down the line. Adverse Event Databases can also be monitored for events specific to your product.
Latest Publications
Post Market Clinical Follow-Up (PMCF) – Understanding MDCG’s Latest Guidance
PMCF Guidance An important constituent of Post Market Surveillance (PMS), Post Market Clinical Follow Up (PMCF) is a continuous lifecycle process, wherein the device’s clinical evaluation is constantly updated, confirming its safety and clinical performance [...]
IVDR Part II – Your Technical Documentation and Performance Evaluation
IVDR Part II - Your Technical Documentation and Performance Evaluation In the previous article we had discussed some of the major changes to be considered in the EU IVDR; namely increased regulatory oversight, expanded [...]
EU IVDR – Part I
The EU IVDR Regulation - An Overview - Part I The PIP breast implant scandal brought to light weaknesses in the overall regulatory process for control of IVDs including, but not limited to, the system [...]
Are You Ready?
Highest Quality – Delivered Consistently
Get Your Meddev Compliant Literature Searches and Post Market Surveillance components completed on-time and without mistakes. We handle the time consuming research while your compliance team focuses on what they do best.