Clinical Literature Review

Clinical literature review is of paramount importance in preparing the clinical evaluation for medical devices to comply to Medical Device Regulation (MDR). This thorough examination of existing research and data on similar devices provides a vital foundation for the evaluation process. It helps identify potential risks, safety concerns, and performance parameters, enabling a comprehensive risk analysis. By leveraging established evidence, manufacturers can ensure their medical devices meet the highest safety and efficacy standards. Moreover, the literature review validates the device's intended use, aiding in producing robust and appropriate clinical data and facilitating the development Clinical Evaluation Report (CER), essential for obtaining MDR compliance.
Services
QMedCo provides
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in depth literature analysis within the framework of PICO analysis to establish a superior base for Clinical Evaluation plan
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State of the Art documentation as a continuously updated reflection of standard of care, current best practices
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Pubmed, Medline and Embase are the databases of choice
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GenexAI to streamline the literature review process