Literature Search & Review for MDR Compliance – Practical Training

Master MDR-compliant literature reviews: planning, appraisal & State of the Art (SOTA) for Medical Devices

Navigating the complexities of MDR-compliant systematic literature searches can be daunting. This hands-on course breaks down the literature search process into actionable steps, providing you with the knowledge and tools needed to effectively plan, execute, and document literature searches to enhance crucial processes such as post-market surveillance, risk management, and clinical evaluations. Through real-world examples and case studies, you will gain practical insights that are directly applicable to your work.

Course description

This hands-on course will equip you with essential skills to efficiently navigate and analyze vast amounts of scientific literature, ensuring compliance and innovation in your MDR processes. You will learn how systematic literature search can enhance processes such as regulatory submissions, risk management, and clinical evaluations. Additionally, discover how processes like product development, post-market surveillance, and quality management can benefit from a structured approach to literature review.

Through real-world examples and case studies, you will gain a deep understanding of best practices, critical analysis techniques, and the ability to synthesize information effectively, empowering you to make informed decisions and drive excellence in your field and the competences to conduct a compliant clinical evaluation.

Course outline

• Planning, Performing, and Documenting Literature Searches: Comprehensive guidance on each phase of literature search, from planning to reporting, according to standards and best practices.
• MDR Processes and Literature Search: Clarifying the deep connections between literature searches and other processes.
• State of the Art Synthesis and Analysis: Critical analysis techniques and information synthesis strategies, ensuring efficiency and compliance.
• Practical Tips and Key Focus Areas: Proven strategies for enhancing literature review quality, ensuring compliance, and mitigating common challenges.
• Case Studies to Solidify Your Knowledge: Real-world examples and exercises to demonstrate application of the best practices and consolidate learning.

Learning objectives

• Designing Your Literature Searches for Your Device: Learn how to design your literature search based on your medical device, the medical field, and the needs of MDR requirements and applicable standards.
• Comprehensive Understanding of the Interactions Between SOTA and MDR Processes: Gain clarity on pivotal role that SOTA plays in other processes, such as product development, post-market surveillance, clinical evaluation and risk management and clinical studies.
• Effective Literature Data Collection and Management: Acquire skills to collect, manage, synthetize, analyze and report the results from literature search.
• Quality Control: Implement pragmatic strategies for enhancing literature review quality, ensuring compliance, and mitigating common challenges.
• Applying Practical Knowledge: Enhance your skills through your case studies and hands-on training that solidify your understanding of the process.

Who should attend

Professionals involved in lifecycle management of medical devices and IVD devices, including but not limited to those involved in clinical evaluation, post-market surveillance and risk management.

Prerequisites

A minimum of 1 year of experience in the medical device/IVD field or related life science sectors.

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