The Medical Devices Introductory Course 2020

Search strategy

• Scientific databases (bibliographic) e.g. MEDLINE, PubMed, EMBASE, OVID • Specialised databases e.g. MEDION • Systematic review databases e.g. Cochrane Collaboration • Clinical trial registers e.g. www.clinicaltrials.gov • Adverse event report databases e.g. MAUDE, IRIS, MHRA • Reference texts

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Literature search

• Should be conducted in a logical and methodical manner • Protocol should be defined (often within the CEP) • Recommended to separate searches for SOTA (broad) and clinical data on device under evaluation (narrow) • Appropriate search terms and filters (e.g. PICO) • Humans, time periods (language limits not recommended) • Inclusion/Exclusion Criteria • Typically two cuts • First cut – based on search terms (broad) • Second cut – based on inclusion/exclusion criteria (narrow) • All results should be presented • Methods to evaluate the weight of each article should be defined • Possible format is available in MEDDEV 2.7.1 rev.4

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