Systematic Literature Review
EXPERIENCED
SKILLED
STRUCTURED
KNOWLEDGEABLE
Literature Plan, Report and Review
'State-of-the-Art' (SOTA)
SotA Literature Reviews to demonstrate clinical association/scientific validity in accordance with the European In Vitro Diagnostic Medical Devices Regulation (IVDR).
In Post-Market Surveillance,
Clinical Evaluation Reporting (CER) and Performance Reporting (CPR).
The European Union strictly regulates Clinical Studies, Medicinal Products, and in vitro Diagnostics to be clinically effective, transparent, fair and ethically correct.
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 systematic literature search strategies and write up plans. Our searches will be thoroughly documented and described. We evaluate the clinical state-of-the-art (SotA) and establish scientific validity data supporting clinical association or performance association.
We write detailed literature search reports with summary, discussion and conclusions.
We write 'State-of-the-Art' (SotA) literature reviews according to the requirements of clinical evidence and scientific validity reporting.
We care about your reporting obligations!