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Data Analysis | Appraisal

Business Meeting

Clinical data analysis and appraisal play a crucial role in the evaluation of medical devices for compliance with the Medical Device Regulation (MDR). It involves a systematic and rigorous examination of the gathered clinical data to assess the safety, performance, and effectiveness of the device. Various data sources, including preclinical and clinical studies, post-market surveillance, and standard of care evidence. The process ensures that the medical device meets the required standards and demonstrates its clinical benefits and risk management. A comprehensive and well-documented analysis is essential to meet MDR requirements.

Services

QMedCo provides

  • analysis of all clinical data and it's compliance with MDR

  • structured and systemic analysis using PRISMA flow diagrams

  • data analysis of all sources : Pre market clinical studies, risk management; PCMF studies, Post Marketing Surveillance reports

  • appraisal of data using a formalised grading system

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