Literature review and Report

A clinical evaluation for a medical device (and performance evaluation for an in-vitro diagnostic medical device) is expected to include a critical evaluation of the relevant scientific literature. The literature search must be based on a methodologically sound and non-biased procedure. Both favourable and unfavourable data must be included for the device under evaluation.

At AML Christensen, we use a systematic literature search strategy to retrieve relevant data from relevant databases such as PubMed, Cochrane Library, TRIP, Google Scholar, clinicaltrials.gov, etc. The objective of the literature review is to identify and appraise clinical experience data to support the clinical safety and performance of the subject device when used per its intended purpose. The literature search is also used to assess the state of the art/current knowledge in the corresponding medical field for the subject device and similar benchmark devices. The state-of-the-art literature searches will be performed according to the PICO approach, which considers P) the target population, patient and problem; I) the intervention; C) the comparison/control; and O) relevant outcomes.

The identified literature will be collected, reviewed and appraised for the content of relevant clinical data related to the safety and performance according to IMDRF MDCE WG/N56FINAL:2019 (ref).

The literature search strategy and results may be documented using AML Christensen’s proven Literature Search Report (LSR) template. The LSR can be filed as a stand-alone document or can be included as an appendix to the Clinical Evaluation Report (CER) / Performance Evaluation Report (PER), depending on your preference. It is also an option that we use your template. We can additionally perform literature searches for other parts of your documentation such as the periodic safety update report (PSUR), post market clinical follow-up (PMCF), pre-clinical product verification and validation, biological evaluation, scientific manuscripts, etc.

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Literature review and Report

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