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Questions Regarding Clinical Evaluation

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Guest user Created:   Feb 14, 2022

Questions Regarding Clinical Evaluation

We have noticed that our current clinical evaluation report does not meet the MDR requirements due to unsatisfactory documentation. Eventhough all clinical tests and results are good enough for proofing the product usage  the consultant company did not properly documented as regulatory requested format and contents .So we need to reorganize CER report  and need a new company/individual  to assist us. Our intention is to work with a competent and reliable agent. In addition to CER work we also need to rework on some tests(Biocompatibility). So I need your guidance and recommendation for selecting a test center and CER process.Do you know any source for recommending us?
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Feb 14, 2022

Feb 14, 2022

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