One key component of MDR compliance is the evidence-based literature review, a rigorous and systematic approach that validates safety, performance and benefits of your device. The literature review is essential for the definition of claims and integral part of the Post-Market Surveillance (PMS), Periodic Safety Update Report (PSUR), Clinical Evaluation Report (CER) and Post-Market Clinical Follow-up (PMCF) Report as required by Annex XIV, Parts A and B of the MDR. In addition, the scientific literature search is the basis for the development of marketing materials like product information and white papers. The literature data shall be continuously collected and evaluated during the whole lifecycle of your device.

• Our service for literature monitoring offers regular monthly literature research for your device in widely used reference databases (e.g., Medline, Embase). We identify relevant scientific and clinical publications, provide you with the results (e.g., for your marketing documents) and evaluate findings in PMS Report, PSUR, CER and PMCF Report. This way, in compliance with MDR requirements, you will ensure that the results had been evaluated consistently.