The CiteMed Edge

CiteMed was founded to help facilitate the widespread regulatory bottleneck poised to impact medical device manufacturers in 2020 with the issuance of the Medical Device Report (MDR) requirements.

The new regulation has no accommodations for lead-in time.  All Medical products and devices must have adhered to these guidelines and be approved through country identified notified bodies in order to be sold and marketed in over 39 countries within the EU.

Resources and expertise in preparing the essential Literature Reviews and Clinical Evaluation Reports (CERs) are becoming limited with the upcoming frenzy caused by this new regulation.   Our solution is both a time-efficient and cost-effective solution for any size company required to maintain a Design History File and Risk Analysis Program.   

Let us help you stay competitive in the European medical device marketplace as a responsible, risk-aware and compliant manufacturer or distributor.

Cost Containment and Immediate Cost Containment

We realize limited resources and budget constraints can delay regulatory submissions and product sales in the European markets.  

See how our proven process, systematically builds each custom Literature Review without minimal internal resources.

  • Predefined Timelines – Our system has established timelines, processes and client decision points built
    in. Web-based integration to your projects keeps you on schedule.

  • Results – Reports are streamlined to include all essential components and regulatory requirements.

  • Experienced Review Team – The Team of reviews have Scientific and Industry experience that provides
    the best balance for critically assessing the relevance of your output and relating these results to the
    interests of safety and efficacy.

At CiteMed, we take the ambiguity out of the process, quickly resulting in a high quality report within a
fixed price model.   Our goal is to get help you get your product to market as quickly as possible, all
while maintaining State of the Art compliance with the European Commission regulations.

Learn More About Our Approach

Do you want Free Analysis of Your Medical Device? Contact us today and receive a preliminary overview of current literature results pertaining to your product

Learn How