Literature Search and Appraisal for Medical Devices

This course provides a structured, regulator-aligned approach to conducting and documenting literature searches and critical appraisal for medical devices across the product lifecycle. Learners will understand the regulatory purpose of literature searches; design reproducible, audit-ready search strategies using PICO and Boolean logic; select appropriate clinical, safety, and regulatory databases; and perform systematic screening and critical appraisal using the MDR, MEDDEV 2.7/1 Rev.4, and IMDRF frameworks. The course emphasizes traceability, bias minimization, and documentation practices required for Clinical Evaluation Reports (CERs), PMS, and regulatory audits.

Link for learner's community: https://neujinsolutions.heightsplatform.com/discuss/literature-search-and-appraisal

The doubt-clearing session is available every week. Please share your specific queries in advance at neulearn@neujinsolutions.com. You will be informed of the date and time in advance.

Note ‘The certificate will be shared via email upon successful course completion’

14 Lessons

₹1,500

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Module 1: Foundations & Regulatory Expectations

This module introduces the regulatory purpose of literature searches and the global guidance governing search and appraisal expectations, and includes a quiz.

Module 2: Literature Sources

This module explains how clinical literature is classified by source and evidentiary value for regulatory decision-making and includes a quiz and two assignments.

Module 3: Search Strategy

This module teaches how to build a structured, reproducible search strategy using PICO, concepts, and keywords and includes a quiz.

Module 4: Selecting Search Databases

This module explains how to select appropriate databases based on device type, technology, and regulatory expectations and includes a quiz and an assignment.

Module 5: Database Searches and PubMed Search (5A)

This module provides overview of database search and demonstrates how to perform a structured PubMed search using PICO, keywords, MeSH terms, Boolean logic, and filters, and includes a video demonstration.

Module 5B: Cochrane Library Search

This module explains how to search the Cochrane Library for systematic reviews and controlled trials.

Module 5C: ClinicalTrials.gov Search

This module demonstrates how to search ClinicalTrials.gov to identify ongoing, completed, and unpublished clinical studies.

Module 5D: MAUDE Search

This module explains how to search the FDA MAUDE database for device-related adverse event and safety information.

Module 5E: Combining Evidence Across Databases

This module explains how to combine and reconcile evidence retrieved from multiple databases to ensure regulatory completeness.

Module 6: Screening & Minimizing Bias

This module introduces systematic screening methods to identify relevant studies while minimizing bias and includes a quiz.

Module 7: Critical Appraisal of Evidence

This module teaches how to critically appraise clinical evidence using MEDDEV and IMDRF-aligned criteria and includes a quiz.

Module 8: Documentation of Search & Appraisal

This module focuses on documenting search and appraisal activities in a regulator-ready, audit-compliant manner and includes a quiz.

Course Resources: Learner’s Handbook & Templates

This section provides access to the learner’s handbook and downloadable templates to support structured learning and practical application of the course content.

Feedback

The goal of this module is to collect feedback from learners