SCIENTIFIC AND CLINICAL LITERATURE EXAMINATION
Quality First International's team of specialists are able to perform a skilled and critical examination of scientific and clinical literature for inclusion in:
- product documentation
- regulatory filings
- meta-analysis or epidemiology
- evidence-based submissions
- ethics approval
- evaluation of concept changes
- evidence of non-inferiority or equivalence
- design modifications
- clarification of cost issues
- discovery of unexpected clinical analysis or tests
- uncovering regulatory pitfalls
- substantiating existing or determining potential for new claims and new uses
- general publication.
Skilful, analytical interpretation and survey of promulgated works will ensure maximum exploitation and use of data, particularly constructive knowledge and definition of prior art.
Fulfils European MEDDEV and other guidance for CE marking purposes, as well as FDA requirements and those of other regulatory domains.