Literature Search Process

national medical solutions

1.  Initial Scope

Speak with you dedicated rep about your products, their classifications and the requirements for your EU MDR Literature Search

  • Define the Target – Identify your goals and the products you intend to market

  • Assess Viability – Determine preliminary time/cost estimates and potential risks

  • Onboarding – Complete initial on-boarding agreements

In this phase, all of your initial questions will be answered. Your proposed products will be vetted to identify their viability for submission, and your dedicated representative will also be able to provide a scope/timeline crafted to your needs.

2. Discovery – Protocol Definition

Work with our team to define search terms relevant to your products.  Our proprietary search tool makes the process of refining search terms and gauging research results effortless and non time consuming for you.

  • 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

Based on your terms and submitted product info, our system will generate a completed and thorough search protocol for you to approve.  This will be the same protocol used by our research team, and in your eventual Notified body submission

Literature Search

3. Research and Writing

Once terms are approved, we pull every article from the agreed Databases and Medical Journals for input into our Review Management System.   An accredited on-staff writer (no faceless consultants here)  then reviews every article and performs all necessary Meddev classifications and conclusion 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

This part of the process is where our Review Management System really shines. All article categorization is auto-assisted enabling our writers to spend the maximum amount of time possible on in-depth analysis and critical writing.   All research articles are stored, and we track their categorizations throughout the entire review process.

4. Report Generation and Review

After the research has been fully reviewed and all classifications are inputted into the system,  we will generate a first draft report for your for review and approval.

  • 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

Upon completion of the research and writing by our team,  the Research Management System will syndicate all classified research, generating a final Report for your approval.  Revisions will be handled immediately to ensure an accurate and final report.


5. Completion and Submission

With a fully completed product, you will now be ready to make your Notified Body submission! 

  • Finalized Submission – Collect your submission paperwork together and include your new Report + Protocol

  • Invoice – An invoice for services rendered will be sent (in accordance with initial protocol)

After your invoice and ultimate submission to the Notified Body, your project with Cite Med will be complete.  On-going compliance and monitoring of research can be established to ensure your products stay compliant in future years.

Learn More About Our Approach

CiteMed is a melting pot of seasoned Regulatory Affairs Professionals and Ex-Silicon Valley Software Engineers. Contact us to find out how our team can meet your EU MDR needs on-time and under budget.