This session’s topic: Systematic Literature Review: What is it and why is it so important?
Do you have specific questions about the steps of the systematic literature review process or questions regarding your medical device or IVD? During this 45-minute Q&A session, our President Laurie Mitchell answers questions about the steps to conduct a methodologically sound SLR. In addition, she discusses how to leverage published data to meet regulatory expectations and inform internal decision-making from marketing initiatives and clinical strategies to global regulatory requirements.
Who should watch this webinar?
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Systematic Literature Reviews for EU MDR or IVDR submissions, meta-analyses, regulatory response support, development of clinical marketing materials, etc.
Watch the recording!
Watch Our Related Webinar for an In-Depth Look at the SLR Process
With the implementation of IVDR and MDR requirements, device manufacturers often struggle to align their internal processes and systems to comply with these rigorous regulations. Consequently, companies realize the need to review published literature for device-specific clinical data. However many manufacturers may not be familiar with or have the capability to perform all steps of the rigorous systematic literature review process, including screening, selection and data extraction.
Watch our webinar where we break down the steps of the SLR process and take a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR). We encourage professionals from the medical device industry to watch as well, as the content is also relevant to MDR requirements, which align closely with IVDR.