This white paper is a companion piece to our popular webinar where we break down the steps of the systematic literature review (SLR) process and take a wholistic approach to conducting an In Vitro Diagnostic Regulation (IVDR)-compliant SLR.
An SLR is far more than an internet search. It is a clear and robust plan for the identification, retrieval, selection, appraisal, and weighting of published data. SLR has long been the “gold standard” process for evidence-based research, especially in the academic and professional arenas. In today’s regulatory landscape where rigorous methodological SLR principles are now being mandated, adopting a transparent and reproducible process for literature reviews is essential. Every methodologically-sound SLR has 5 clearly defined steps.
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There’s no substitute for experience. Not just writing experience, but industry experience – collectively, the CE team represents over 4 decades of direct industry experience. The team is among the best in the business. Top-flight, advanced-degree clinical professionals with years of experience writing an array of regulatory reports for medical device manufacturers and pharmaceutical and biologics companies.
To learn more about how Criterion Edge can help you achieve your regulatory goals, see criterionedge.com, or contact the company at info@criterionedge.com or, by phone, at +1-805-202-5520
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