Medical device manufacturer leverages Indegene's systematic REP to mitigate inconsistent product risk-related information
Medical device manufacturer leverages Indegene's systematic REP to mitigate inconsistent product risk-related information
2 PagesA top 10 medical device manufacturer with a strong presence in cardiovascular and diabetes care leveraged Indegene's systematic Risk Evaluation Process (REP) to mitigate inconsistent product risk-related information. Challenges included fragmented risk data across multiple sources like Instructions for Use (IFU), labels, Risk Management Files (RMF), Clinical Evaluation Reports (CER), Technical Dossiers, Patient Guides, and Leaflets, plus inadequate anticipated/observed Adverse Event (AE) data. Indegene's advanced software centralized and standardized risk information extraction, automated cross-source reconciliation, and enhanced AE data completeness. This ensured consistent, comprehensive risk documentation and improved product safety compliance.
