Clinical Practices Audits for Medical Devices
The Medical Device Regulation (EU) 2017/745 (MDR) and 2017/746 (IVDR) consider the Clinical evidence an essential part of the Technical Documentation of the devices.
GemarMed can provide regulatory assessment of the clinical evaluation of the manufacturers, procedures and documentation for CER, Clinical Investigation, PMCF, as well as the justification in relation to non-performance of PMCF.
The purpose of the clinical audit is assessing the MDR compliance and to guide manufacturers in complying with the requirements of the MDR/IVDR with respect to obtain sufficient clinical evidence, in view of the audit from the Notified Body.
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