We write medical device Clinical Evaluation Report (CER) to file with China FDA.
Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device.—Global Harmonization Task Force
We are experienced in the literature review part of compiling a CER.
There are several stages:
Stage 1: identify clinical data from literature search;
Stage 2: literature screening and selection, in terms of its suitability, applicability, quality and clinical significance. Some publications are excluded according to exclusion criteria. For potentially eligible literature, full texts are consulted for a more detailed assessment. More papers are excluded at this time.
Stage 3: Papers with relevant, usable data on device performance and safety are included in the clinical evaluation analysis. Detailed appraisal criteria for suitability are used and Oxford Level of Evidence is assigned to all included papers.
The literature summary is then incorporated into the CER, together with other sections to form a complete CER report.
One representative CER writing project involves evaluating 287 clinical papers and including 92 of them for the CER.
We also work on English to Chinese CER translations to file with China FDA. For a CER project series with a top 10 medical device company, we have completed 4 CER translations - each around 100 pages, with more translation in the pipeline.
AMC has teamed up with a US-based top medical device CER writing company. With streamlined processes, we deliver both English and Chinese CERs as a complete package.