Systematic Literature Review
EXPERIENCED
SKILLED
STRUCTURED
KNOWLEDGEABLE
Literature Plan, Report and Review
According to the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) -
in Post-Market Surveillance,
Clinical Evaluation or Performance Reporting (CER, CPR).
The European Union strictly regulates Clinical Studies, Medicinal Products, and Medical Devices to be clinically effective, transparent, fair, ethically correct, and based on Good Clinical Practice (GCP).​
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The EU Regulation 2017/746 on in vitro medical devices specifies the literature review methodology and practices for an unbiased and objective assessment of the clinical evaluation and performance of an IVD product.
We provide literature search strategies and document these in literature search plans. Searches will be thoroughly performed and documented using state of the art reference managing software.
We write detailed literature search reports with summary, discussion and conclusion, and also reformat text and data according to the requirements of your specific reports.
We care about your reporting obligations!
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