Data Analysis | Appraisal

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
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analysis of all clinical data and it's compliance with MDR
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structured and systemic analysis using PRISMA flow diagrams
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data analysis of all sources : Pre market clinical studies, risk management; PCMF studies, Post Marketing Surveillance reports
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appraisal of data using a formalised grading system
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