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Medical device manufacturer leverages Indegene's systematic REP to mitigate inconsistent product risk-related information ​

The Customer

A top 10 medical device manufacturer with a strong foothold in the cardiovascular and diabetes care market was looking for a partner who could help in the mitigation of the inconsistency of risk-related information in their product documentation through a systematic risk evaluation process (REP).


  • 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 such as quality, clinical, and regulatory managing risk related information without connecting the dots between critical processes such as 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 such as IFU, labels, patient guides, patient leaflets, CER, and RMF leading to delayed regulatory approvals​

The Solution: Regulatory writers and medical reviewers with MDD/MDR knowledge

Indegene established a dedicated team of highly skilled regulatory writers and medical reviewers with deep domain and Medical Devices Directive (MDD)/Medical Device Regulation (MDR) knowledge to partner with the customer to establish a systematic risk evaluation process to document all product risk information in a Risk Evaluation File (REF)​

We 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​

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

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

The output of the risk evaluation process was the REF, which ensured that the risk information was consistent and accurate across all upstream and downstream product technical documentation​


Through the implementation of a systematic risk evaluation process (REP), Indegene was able to successfully address the customer’s challenge of inconsistency in risk-related information across various product technical documents. The customer was able to achieve a remarkable enhancement in the accuracy and consistency of risk information. Additionally, the streamlining of the documentation process and connecting critical functions like clinical evaluation, risk management, and post-market surveillance, ensured a comprehensive and unified strategy in managing product risks.


REF and FAE generated annually


Efficiency leveraging time zones and CoE model


Products achieved EU MDR recertification

Discover how Indegene's proven systematic risk evaluation processes can optimize your medical device documentation. Contact us today to optimize your documentation and ensure regulatory compliance.

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