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Indegene helps author over 135 Risk Evaluation Files (REF) in a year to effectively manage inconsistent product-related risk information

The Customer

A leading global healthcare company with a strong focus on medical devices, including cardiovascular, diabetes care, and neuromodulation devices. The customer was seeking Risk management solutions to ensure the safety and efficacy of their products throughout their life cycle.

The Need

  • Risk Information Inconsistency- Multiple and varying sources of risk information-Instruction For Use (IFU), labels, Risk Management File (RMF), Clinical Evaluation Report (CER), Technical Dossier, patient guides, patient leaflets, etc.​

    Inadequate Data- Limited availability of anticipated/observed Adverse Event (AE) data to identify new risks​

    Process Silos- Different functions like quality, clinical, and regulatory managing risk related information without connecting the dots between critical processes like clinical evaluation, risk management, and post market surveillance​

    Increased Deficiency Reports during Notified Body reviews due to variations and inconsistency in risk information across various product technical documents like IFU, labels, patient guides, patient leaflets, CER, RMF leading to delayed regulatory approvals​

The Solution

Established a team of experienced regulatory writers and medical reviewers with specialized knowledge of MDD/MDR regulations to help customers document product risk information in a systematic manner

Templatized the risk evaluation file and assimilation process

Gap analysis done between IFU /FMEA (failure mode effected analysis) - map failure modes, identify hazards, assign as warning/precaution based on severity and occurrence/probability rates​

Listed AEs from various sources – IFU, CER, Clinical Study Reports (CSRs), literature articles, hazard analysis, FMEA,RMR, and competitor labels.​

Analyzed AE sources for AE frequency rates​

Identified geographic variability, product specificity, type of risk (contraindication-warning-precaution) variability, and analyzed information for EU MDR specific sections – intended clinical benefit/critical warnings/notice on materials list/limitations/incident reporting​



Increase in global product risk evaluation and assimilation process


Annually generated Risk Evaluation Files (REF) & Frequency of Adverse Events (FAE)


Vascular Products achieved EU MDR recertification from BSI

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