Hi Caique
There's really not much literature around specifically about medical device clinical evaluation and PMCF, but as a clinical evaluation is basically an applied type of a systematic review, you should look for the vast body of literature for clinical reviews and apply them (or adapt when required).
In the specific case of appraisal, one book that I like (and one of the only ones I found specifically for appraisal) is this -Making Sense of Critical Appraisal by Olajide Ajetunmobi.
You can find appraisal chapters in other books related to the literature review or evidence-based medicine, in particular, I would recommend the classic Users' Guides to the Medical Literature: Essentials of Evidence-Based Clinical Practice, by JAMA Evidence.
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Marcelo Antunes
Regulatory Strategy Consultant
São Paulo
Brazil
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Original Message:
Sent: 15-Jul-2020 20:53
From: Caique Mancini
Subject: CLINICAL LITERATURE APPRAISAL
Hi guys, my name is Caique.
I am Biomedical and i started to study about Clinical Evaluation e PMCF.
anyone recomend some literature about
- Appraisal Criteria for Relevance (Evidence)
- Appraisal Criteria for Quality of Data Contribution
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Caique Mancini
RIO CLARO
Brazil
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