Literature Route for Clinical Evaluation | MDV-Solve
Clinical Evaluation
Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device.
We help with:
- Clinical Evaluation Plan (CEP)
- Systematic Literature Review
- Clinical Evaluation Report (CER)
- Post-Market Clinical Follow-up (PMCF) planning
- Gap analysis against MEDDEV 2.7/1 Rev 4 and MDR
Related Services
Clinical Evidence — IVDR
Under IVDR Article 56 - clinical data and performance evaluation results for device safety assessment.
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The purpose is to enable you to establish and implement an effective tailored QMS system …
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Integration of a risk management system into your existing quality management system.
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