Clinical evaluation is a structured ongoing procedure to gather, appraise and analyse clinical data relavant to medical device. The aim of clinical evaluation is to assess whether the available clinical evidence is sufficient to verify compliance with relevant essential Requirements for safety and performance of the medical device.Literature search is a clear and methodologically sound plan for the identification, retrieval, selection, and appraisal and to lay weightage for the published data. It is commonly used strategy or a way of collecting evidence on a given research question, mainly for a Clinical Evaluation Report.

The key stages in conducting a systematic review are scoping, screening, planning, eligibility and identification (of relavant ones). In scoping frame one or more research questions about the topic based on PICO (P- Population, I- Intervention, C- Control or Comparison, O- Outcome). Depending on the device the PICO framework can be adapted to include T-time (PICOT), S- Study design (PICOS) or C- Context (PICOS). Like keeping in mind what do you want to know and about medical device, who will be the audience, having clear idea of the relavant finding to address the research question(s). Search terms will operationalize the research question(s) and help to find as many as relevant articles as possible to include. The alternative terms and concepts which address the same question used to describe the same type or research area by considering the synonyms, singular/plural forms, verbal forms, adjectives, different spellings and broader/narrower terms. Fda Certificate

List of inclusion and exclusion criteria need to be addressed to the research question(s) to ensure the quality and resemblance of the included studies and evidently define the limitations of the review. Studies that are eligible for inclusion will meet the inclusion criteria and will not meet the exclusion criteria. Common inclusion and exclusion criteria are Research question (topic, scope), Definition or concept (terms and concepts are often defined differently), Key words, Research design (e.g., observational studies, experimental studies, quantitative studies, qualitative studies), Participants (e.g., adult, infants, Neonates), time frame (e.g. since the start of the literature, since the last review), clinical data.

Before carrying out any searching and selecting the literature, it is required to create one or more record keeping systems for recording the same as if need for any repeat or checking this record will save the time. The steps need to follow are a) Record the details of the searches did and the results, b) need to make a list of the number of studies excluded at the screening stage (i.e. based on their Title and/or Abstract), c) record the list of studies excluded to be made in a table (i.e. based on reading the full-text), along with reasons for excluding the study based on the considered inclusion and exclusion criteria. d) Unpublished data. The Systematic review to be present in a flow diagram of literature searching and selecting process (e.g., The PRISMA flow diagram).

To obtain the required clinical data different sources like scientific databases, internet searches, non-published data, and citations are used. Databases are selected based on a)relevant to the topic or device (e.g. Medline, EMBASE, Cochrane etc) , b)which part of the articles need to be searched ( eg abstract, full text, title), using limits and filters within the databases for search (e.g. review articles and research syntheses etc..), subject categories, sub-headings, etc, c) using Boolean search operators to broaden or narrow the search, d) using ‘AND’, ‘OR’ , ‘NOT’. e) Using a truncation symbol to look for all words like *, #, $ etc. f) Using a wildcard symbol to stand-in for one character (‘#’ or ‘?’ or ‘$ depending on data base) g) using the truncation symbol (*) between words and so on. Literature Search Protocol

Additional searches to be conducted to ensure all relevant published and unpublished data is captured. The full text screening of the included articles to determine the relevancy. The inclusion and exclusion criteria designed will ensure that high-quality relevant studies are included. The relavant data which is selected from the full text review will be considered for the each reports for each review question. This report will cover the results of the data that address the aspects like safety, performance, benefits to patient, side-effects, adverse reactions, state of the art etc.

A precise literature search will not only provides exact evidence but also saves time and efforts during collection of such data. Systematic reviews mainly resolve the problems by identifying, critically evaluating and integrating the findings of all relevant, high-quality individual studies addressing one or more research questions hence the search for literature in systematic way forms an important part of clinical evaluation