Indegene helped a leading global healthcare company focused on cardiovascular, diabetes care, and neuromodulation devices author over 135 Risk Evaluation Files (REF) in a year, strengthening control over inconsistent product-related risk information. The organization needed robust risk management to ensure product safety and efficacy across the life cycle while improving global risk evaluation and assimilation. Indegene’s advanced software streamlined REF creation, centralized fragmented data from multiple sources, and standardized documentation. By automating risk evaluation workflows and integrating adverse event frequency insights, it boosted process efficiency by 20%, generated 30+ FAEs annually, and supported EU MDR recertification for vascular products.

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