The recent adoption of Reg 2017/745 (the latest MDR from the European commission) now places an increased compliance burden on manufacturers. This result becomes especially apparent in the newly defined risk assessment portion of the Clinical Evaluation Report. These Literature Searches and accompanying reviews are now a critical component in product evaluation and also are noticeably more complex.
Those with experience in submissions compliant with the new directive are aware of how labor intensive the Literature Review portion can be to assemble as an individual writer.
There are several significant challenges that writers of Literature Searches now face.
- Classification of many Articles/Studies across multiple research databases
- Formatting of final product
- Cost of revisions and error corrections
The above points can cost your organization substantial amounts of time, and lead to delayed deliverables and frustrated clients who are anxious to start making Notified Body submissions.
Our objective at CiteMed, is to leverage our technology and perform Literature Reviews of the highest quality in the Industry while simultaneously adhering to the shortest deadlines. We take the most arduous part of the process and streamline into a modular component of your firms existing workflow in order to speed up your delivery time and increase your project profit margins.
We are a Research Service that produces MDR submission ready Literature Reviews
Our literature Review service produces a modular and MDR submission compliant deliverable to be included in a full Clinical Evaluation Report and ultimately a CE Marking filing.
We enable external writers and consultants to focus their efforts on highest level of strategy and product analysis while we deliver the formatting and mass data organization required in a high quality Literature Review.
Even the most fundamental tasks such as creating summary tables for Included/Excluded research articles can take an individual days at the scale now required by EU MDR. Our Review Management System enables our writers to completely remove the research formatting burden from your staff and focus on the intellectual analysis required of the encompassing CER.
By using the CiteMed process, you will be delivered a perfectly formatted and error free Literature Review on a timeline that will shock your clients and a price that will ultimately increase your margins on the project.
When we first started CiteMed, our aim was to build a software system that made the oftentimes painful process of conducting Literature Searches streamlined and consistent. Because of this system, we have 10x’d our writer’s productivity by allowing them to focus exclusively on the primary objective of a Literature Review (reviewing articles and writing analysis).
It’s no secret that the heavy lifting in the creation of a CER is the processing of research, so let us deliver that piece for you on the fastest timeline in the industry. Speak with an account manager today and request a sample Literature Review.