Conducting a systematic literature review is a crucial step in the clinical evaluation reporting process under EU MDR. It involves gathering and analyzing relevant clinical literature to support the safety and efficacy of medical devices. However, this process can be time-consuming and challenging without a well-defined approach. In this blog post, we will explore the concept of systematic literature review and provide insights into streamlining this essential task.
What is Systematic Literature Review? Systematic literature review is an algorithmic process that involves refining and analyzing a vast universe of literature related to a specific medical device. The goal is to identify and select relevant articles that provide valuable insights into the device’s safety and effectiveness. This process requires a meticulous approach to ensure that the results obtained are reliable and comprehensive.
The Process of Performing a Systematic Literature Review:
- Defining Search Terms: The first step in conducting a systematic literature review is to determine the search terms and databases to be used. This initial selection should strike a balance between being too broad and too narrow, ensuring that the search yields a manageable number of results.
- Refining the Search: Once the initial search is conducted, it is essential to refine the results. This involves analyzing the obtained articles and adjusting the search terms to narrow down the focus. The goal is to find a manageable amount of literature that is relevant to the device under evaluation.
- Documentation: Throughout the literature review process, it is crucial to document every step taken, including the search terms used, databases searched, and the rationale behind refining the search. This documentation serves as evidence of the thoroughness and reliability of the review.
- Analysis and Compilation: After obtaining the relevant literature, the next step is to analyze and compile the findings. This involves extracting key information, such as study methodologies, results, and conclusions, and organizing them in a structured manner. This compilation serves as the foundation for the clinical evaluation report.
Streamlining the Systematic Literature Review Process: To streamline the systematic literature review process, innovative tools and approaches can be employed. These tools help automate certain aspects of the review, such as database searches and data extraction, reducing the clerical burden on reviewers. Additionally, utilizing software specifically designed for literature review can enhance efficiency and accuracy.
Conclusion: Systematic literature review is a critical component of the clinical evaluation reporting process for medical device companies. By following a well-defined and systematic approach, manufacturers can ensure that their evaluations are comprehensive, reliable, and well-documented. Embracing innovative tools and approaches can further streamline this process, making it more manageable and optimized.
Remember, conducting a systematic literature review requires careful attention to detail and adherence to a defined process. By doing so, manufacturers can confidently demonstrate the safety and effectiveness of their medical devices based on robust scientific evidence.
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